<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03267537</url>
  </required_header>
  <id_info>
    <org_study_id>1545864655443n/a</org_study_id>
    <nct_id>NCT03267537</nct_id>
  </id_info>
  <brief_title>Non-inferiority Study of Telemedicine Versus Conventional CBT-I in Recently Hospitalized Patients With Insomnia</brief_title>
  <official_title>Non-inferiority Study of Telemedicine Versus Conventional CBT-I in Recently Hospitalized Patients With Insomnia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Arizona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Academy of Sleep Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Arizona</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Insomnia is a common medical condition that has a deleterious effect on emotional status,&#xD;
      health-related quality of life, and has been associated with hospitalizations and all-cause&#xD;
      mortality. Recently hospitalized patients who are recuperating in their homes would find it&#xD;
      difficult to return for weekly visits with a clinical psychologist and therefore could&#xD;
      benefit from the convenience of CBT-I treatment administered in the comfort of their homes&#xD;
      via the wireless iPAD and video chat software. In patients who are recently discharged from&#xD;
      the hospital, we wish to assess whether telemedicine-based CBT-I is comparable to&#xD;
      conventional office-based CBT-I in the efficacy for treating insomnia. Research aiming to&#xD;
      improve understanding of whether insomnia represents a modifiable risk factor for&#xD;
      re-hospitalizations in patients who are high utilizers of healthcare services is an important&#xD;
      area of future research.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Insomnia is a common and distressing medical condition that affects nearly 20% of U.S.&#xD;
      adults, and persistent (or chronic) insomnia affects nearly 10-15% of U.S. adults. In a&#xD;
      community-based prospective observational study, preliminary data suggests that insomnia is&#xD;
      associated with hospitalizations due to cardiovascular, cancer, or any cause over a 4-year&#xD;
      period. Cognitive Behavioral Therapy for Insomnia (CBT-I) is considered the gold-standard in&#xD;
      the treatment of insomnia. There are 5 components of CBT-I, sleep restriction therapy,&#xD;
      stimulus control instructions, relaxation training, cognitive therapy, and sleep hygiene&#xD;
      education. In an ongoing study of CBT-I in recently hospitalized patients, the investigators&#xD;
      found a high prevalence of insomnia (80%) and were able to administer CBT-I in the&#xD;
      participants' home via iPADs with wireless connectivity and secure video-chat software.&#xD;
      Recently hospitalized patients who are recuperating in their homes would find it difficult to&#xD;
      return for weekly visits with a clinical psychologist and therefore could benefit from the&#xD;
      convenience of CBT-I treatment administered in the patient's homes via the wireless iPAD and&#xD;
      video chat software. The AASM SleepTM platform could conceivably allow performance of CBT-I&#xD;
      without the added expense of an iPAD. The investigators are proposing to perform a&#xD;
      non-inferiority trial of telemedicine CBT-I (AASM SleepTM) versus conventional office-based&#xD;
      CBT-I that is performed in patients with insomnia who have been recently discharged from the&#xD;
      hospital. The investigators will measure the following outcomes: insomnia severity index&#xD;
      (primary outcome) and patient satisfaction. In the future, the investigators' program of&#xD;
      research aims to improve understanding of whether insomnia represents a modifiable risk&#xD;
      factor for re-hospitalizations in patients who are high utilizers of healthcare services.&#xD;
&#xD;
      Specific Aim 1: To perform comparative effectiveness research of CBT-I administered by&#xD;
      telemedicine versus conventional office-based CBT-I on insomnia severity in recently&#xD;
      hospitalized patients.&#xD;
&#xD;
      Hypothesis #1: In recently hospitalized patients with insomnia, after six weeks of CBT-I&#xD;
      treatment, the mean improvement in ISI score among patients treated by telemedicine CBT-I&#xD;
      (AASM SleepTM) would be no more than 3-points less than that in patients treated by&#xD;
      conventional office-based CBT-I.&#xD;
&#xD;
      Specific Aim 2: To perform comparative effectiveness research of CBT-I administered by&#xD;
      telemedicine versus conventional office-based CBT-I on patient satisfaction.&#xD;
&#xD;
      Hypothesis #2: In recently hospitalized patients with insomnia, after six weeks of CBT-I&#xD;
      treatment, the mean improvement in patient satisfaction score (Consumer Assessment of Health&#xD;
      Plans Survey [CAHPS v4.0] item) among patients treated by telemedicine CBT-I (AASM SleepTM)&#xD;
      would be no more than 1-point less than that in patients treated by conventional office-based&#xD;
      CBT-I.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 13, 2017</start_date>
  <completion_date type="Anticipated">May 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomized Controlled Trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>Observers will be blinded to subjects group assignment</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Insomnia Severity Index (ISI)</measure>
    <time_frame>Baseline and after receiving CBT-I (~6 weeks)</time_frame>
    <description>A 7-item questionnaire used to assess insomnia severity with a score ranging between 0 to 28. Each questionnaire item addresses an aspect about sleep that is rated by the respondent on a 5-point scale (i.e., 0=no problem &amp; 4=very severe problem) Change in ISI score will be assessed between baseline and following CBT-I treatment over a 6 week period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Consumer Assessment of Health Plans Survey (CAHPS v4.0) item</measure>
    <time_frame>Administered at baseline and at the end of receiving CBT-I (~6 weeks)</time_frame>
    <description>Health plan member's satisfaction with care on 0 to 10 scale (0 is the &quot;worst &quot; and 10 is the &quot;best health plan possible&quot;). Change in CAHPS score will be measured</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Wake After Sleep Onset (WASO)</measure>
    <time_frame>Sleep diaries are completed daily and actiwatch is worn continuously during the treatment period (~6 weeks)</time_frame>
    <description>WASO is defined as the number of minutes spent awake after sleep onset. This is going to be measured by wrist actigraphy and sleep diaries. Change in WASO will be assessed over the intervention period</description>
  </other_outcome>
  <other_outcome>
    <measure>Sleep Onset Latency (SOL)</measure>
    <time_frame>Sleep diaries are completed daily and actiwatch is worn continuously during the treatment period (~6 weeks)</time_frame>
    <description>SOL is the number of minutes that it takes to fall asleep. This is going to be measured by wrist actigraphy and sleep diaries. Change in SOL will be assessed over the intervention period</description>
  </other_outcome>
  <other_outcome>
    <measure>Pittsburgh Sleep Quality Index (PSQI)</measure>
    <time_frame>Administered at baseline and at the end of receiving CBT-I (~6 weeks)</time_frame>
    <description>Provides a subjective assessment of sleep quality. Change in PSQI score will be assessed between baseline and 6-week follow-up.</description>
  </other_outcome>
  <other_outcome>
    <measure>SF-36 Health Survey</measure>
    <time_frame>Administered at baseline, at the end of receiving CBT-I (~6 weeks), at 2 weeks following treatment, and at 12 weeks following treatment</time_frame>
    <description>A 36 item health status assessment tool, which measures general health and quality of life. Change in various dimensions of the SF-36 will be assessed over the 6-week period.</description>
  </other_outcome>
  <other_outcome>
    <measure>Re-hospitalizations</measure>
    <time_frame>Administered at the time of hospital discharge and at the end of receiving CBT-I (~6 weeks)</time_frame>
    <description>Composite number of hospital readmissions over 6 weeks.</description>
  </other_outcome>
  <other_outcome>
    <measure>Healthcare utilization</measure>
    <time_frame>Administered at the time of hospital discharge and at the end of receiving CBT-I (~6 weeks)</time_frame>
    <description>Composite number of visits to any of the following locations of healthcare service for care delivery: Emergency room, urgent care, as well as unscheduled and scheduled clinic visits.</description>
  </other_outcome>
  <other_outcome>
    <measure>Epworth Sleepiness Scale (ESS)</measure>
    <time_frame>Administered at baseline and at the end of receiving CBT-I (~6 weeks)</time_frame>
    <description>A measure of sleepiness. Change in ESS score will be assessed</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">74</enrollment>
  <condition>Insomnia</condition>
  <arm_group>
    <arm_group_label>Conventional office-based CBT-I</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>CBT-I will be delivered by a licensed clinical psychologist in weekly sessions lasting up to 1 hour. There will be 6 CBT-I sessions over the course of therapy with the option of an additional 2 treatments if deemed necessary by the clinical psychologist.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Telemedicine based CBT-I</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The treatment will be the exact same as the active comparator group, with the same clinical psychologist doing the office-based CBT-I, but will be administered through a telemedicine modality</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Telemedicine CBT-I</intervention_name>
    <description>Will be administered in a manner similar to the conventional CBT-I arm except that the patient would not be required to make office visits</description>
    <arm_group_label>Telemedicine based CBT-I</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Conventional office-based CBT-I</intervention_name>
    <description>Conventional office-based CBT-I</description>
    <arm_group_label>Conventional office-based CBT-I</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Medically ill patients with recent hospitalization who are being discharged to home.&#xD;
&#xD;
          -  ISI score of &gt; 10 (chronic insomnia)&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  Ability to provide informed consent&#xD;
&#xD;
          -  Willingness to undergo sleep study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of untreated sleep disorder that requires treatment independent of insomnia&#xD;
             (Narcolepsy, restless leg syndrome, or REM sleep behavior disorder)&#xD;
&#xD;
          -  Patients with severe debilitating neurological disease (end-stage Alzheimer's, large&#xD;
             stroke, or other debilitating neurological disease) or any other condition that&#xD;
             renders patients incapable of providing informed consent&#xD;
&#xD;
          -  History of Bipolar disease; current or past (&lt; 6 months) history of suicidality or&#xD;
             suicidal ideation&#xD;
&#xD;
          -  Active substance abuse or alcoholism&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Sairam Parthasarathy, MD</last_name>
    <phone>(520) 626-6109</phone>
    <email>sparthasarathy@deptofmed.arizona.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Arizona (Banner University Medical Center - Tucson &amp; Banner University Medical Center - South)</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85721</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sairam Parthasarathy, MD</last_name>
      <phone>520-626-6109</phone>
      <email>sparthasarathy@deptofmed.arizona.edu</email>
    </contact>
    <contact_backup>
      <last_name>Chris Morton</last_name>
      <phone>5206268457</phone>
      <email>cjmorton@email.arizona.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Buysse DJ. Insomnia. JAMA. 2013 Feb 20;309(7):706-16. doi: 10.1001/jama.2013.193.</citation>
    <PMID>23423416</PMID>
  </reference>
  <reference>
    <citation>Kyle SD, Morgan K, Espie CA. Insomnia and health-related quality of life. Sleep Med Rev. 2010 Feb;14(1):69-82. doi: 10.1016/j.smrv.2009.07.004. Epub 2009 Dec 4.</citation>
    <PMID>19962922</PMID>
  </reference>
  <reference>
    <citation>Parthasarathy S, Vasquez MM, Halonen M, Bootzin R, Quan SF, Martinez FD, Guerra S. Persistent insomnia is associated with mortality risk. Am J Med. 2015 Mar;128(3):268-75.e2. doi: 10.1016/j.amjmed.2014.10.015. Epub 2014 Oct 16.</citation>
    <PMID>25447616</PMID>
  </reference>
  <reference>
    <citation>Foley DJ, Monjan AA, Brown SL, Simonsick EM, Wallace RB, Blazer DG. Sleep complaints among elderly persons: an epidemiologic study of three communities. Sleep. 1995 Jul;18(6):425-32. doi: 10.1093/sleep/18.6.425.</citation>
    <PMID>7481413</PMID>
  </reference>
  <reference>
    <citation>Althuis MD, Fredman L, Langenberg PW, Magaziner J. The relationship between insomnia and mortality among community-dwelling older women. J Am Geriatr Soc. 1998 Oct;46(10):1270-3. doi: 10.1111/j.1532-5415.1998.tb04544.x.</citation>
    <PMID>9777910</PMID>
  </reference>
  <reference>
    <citation>Newman AB, Spiekerman CF, Enright P, Lefkowitz D, Manolio T, Reynolds CF, Robbins J. Daytime sleepiness predicts mortality and cardiovascular disease in older adults. The Cardiovascular Health Study Research Group. J Am Geriatr Soc. 2000 Feb;48(2):115-23. doi: 10.1111/j.1532-5415.2000.tb03901.x.</citation>
    <PMID>10682939</PMID>
  </reference>
  <reference>
    <citation>Rockwood K, Davis HS, Merry HR, MacKnight C, McDowell I. Sleep disturbances and mortality: results from the Canadian Study of Health and Aging. J Am Geriatr Soc. 2001 May;49(5):639-41. doi: 10.1046/j.1532-5415.2001.49125.x.</citation>
    <PMID>11380758</PMID>
  </reference>
  <reference>
    <citation>Nilsson PM, Nilsson JA, Hedblad B, Berglund G. Sleep disturbance in association with elevated pulse rate for prediction of mortality--consequences of mental strain? J Intern Med. 2001 Dec;250(6):521-9. doi: 10.1046/j.1365-2796.2001.00913.x.</citation>
    <PMID>11902821</PMID>
  </reference>
  <reference>
    <citation>Mallon L, Broman JE, Hetta J. Sleep complaints predict coronary artery disease mortality in males: a 12-year follow-up study of a middle-aged Swedish population. J Intern Med. 2002 Mar;251(3):207-16. doi: 10.1046/j.1365-2796.2002.00941.x.</citation>
    <PMID>11886479</PMID>
  </reference>
  <reference>
    <citation>Suzuki E, Yorifuji T, Ueshima K, Takao S, Sugiyama M, Ohta T, Ishikawa-Takata K, Doi H. Sleep duration, sleep quality and cardiovascular disease mortality among the elderly: a population-based cohort study. Prev Med. 2009 Aug-Sep;49(2-3):135-41. doi: 10.1016/j.ypmed.2009.06.016. Epub 2009 Jun 30.</citation>
    <PMID>19573557</PMID>
  </reference>
  <reference>
    <citation>Rod NH, Vahtera J, Westerlund H, Kivimaki M, Zins M, Goldberg M, Lange T. Sleep disturbances and cause-specific mortality: Results from the GAZEL cohort study. Am J Epidemiol. 2011 Feb 1;173(3):300-9. doi: 10.1093/aje/kwq371. Epub 2010 Dec 30.</citation>
    <PMID>21193534</PMID>
  </reference>
  <reference>
    <citation>Almeida OP, Alfonso H, Yeap BB, Hankey G, Flicker L. Complaints of difficulty to fall asleep increase the risk of depression in later life: the health in men study. J Affect Disord. 2011 Nov;134(1-3):208-16. doi: 10.1016/j.jad.2011.05.045. Epub 2011 Jun 15.</citation>
    <PMID>21680026</PMID>
  </reference>
  <reference>
    <citation>Eaker ED, Pinsky J, Castelli WP. Myocardial infarction and coronary death among women: psychosocial predictors from a 20-year follow-up of women in the Framingham Study. Am J Epidemiol. 1992 Apr 15;135(8):854-64. doi: 10.1093/oxfordjournals.aje.a116381.</citation>
    <PMID>1585898</PMID>
  </reference>
  <reference>
    <citation>Vgontzas AN, Liao D, Pejovic S, Calhoun S, Karataraki M, Basta M, Fernandez-Mendoza J, Bixler EO. Insomnia with short sleep duration and mortality: the Penn State cohort. Sleep. 2010 Sep;33(9):1159-64. doi: 10.1093/sleep/33.9.1159.</citation>
    <PMID>20857861</PMID>
  </reference>
  <reference>
    <citation>Li Y, Zhang X, Winkelman JW, Redline S, Hu FB, Stampfer M, Ma J, Gao X. Association between insomnia symptoms and mortality: a prospective study of U.S. men. Circulation. 2014 Feb 18;129(7):737-46. doi: 10.1161/CIRCULATIONAHA.113.004500. Epub 2013 Nov 13.</citation>
    <PMID>24226807</PMID>
  </reference>
  <reference>
    <citation>Haynes PL, Parthasarathy S, Kersh B, Bootzin RR. Examination of insomnia and insomnia treatment in psychiatric inpatients. Int J Ment Health Nurs. 2011 Apr;20(2):130-6. doi: 10.1111/j.1447-0349.2010.00711.x.</citation>
    <PMID>21371228</PMID>
  </reference>
  <reference>
    <citation>Morin CM, Belleville G, Belanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8. doi: 10.1093/sleep/34.5.601.</citation>
    <PMID>21532953</PMID>
  </reference>
  <reference>
    <citation>Schmittdiel J, Mosen DM, Glasgow RE, Hibbard J, Remmers C, Bellows J. Patient Assessment of Chronic Illness Care (PACIC) and improved patient-centered outcomes for chronic conditions. J Gen Intern Med. 2008 Jan;23(1):77-80. doi: 10.1007/s11606-007-0452-5. Epub 2007 Nov 21.</citation>
    <PMID>18030539</PMID>
  </reference>
  <reference>
    <citation>Michelson D, Snyder E, Paradis E, Chengan-Liu M, Snavely DB, Hutzelmann J, Walsh JK, Krystal AD, Benca RM, Cohn M, Lines C, Roth T, Herring WJ. Safety and efficacy of suvorexant during 1-year treatment of insomnia with subsequent abrupt treatment discontinuation: a phase 3 randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2014 May;13(5):461-71. doi: 10.1016/S1474-4422(14)70053-5. Epub 2014 Mar 27.</citation>
    <PMID>24680372</PMID>
  </reference>
  <reference>
    <citation>Morin CM, Vallieres A, Guay B, Ivers H, Savard J, Merette C, Bastien C, Baillargeon L. Cognitive behavioral therapy, singly and combined with medication, for persistent insomnia: a randomized controlled trial. JAMA. 2009 May 20;301(19):2005-15. doi: 10.1001/jama.2009.682.</citation>
    <PMID>19454639</PMID>
  </reference>
  <reference>
    <citation>Buysse DJ, Ancoli-Israel S, Edinger JD, Lichstein KL, Morin CM. Recommendations for a standard research assessment of insomnia. Sleep. 2006 Sep;29(9):1155-73. doi: 10.1093/sleep/29.9.1155. Erratum In: Sleep. 2006 Nov 1;29(11):1380.</citation>
    <PMID>17040003</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>June 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>August 31, 2017</last_update_submitted>
  <last_update_submitted_qc>August 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Arizona</investigator_affiliation>
    <investigator_full_name>Sairam Parthasarathy</investigator_full_name>
    <investigator_title>Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>Insomnia</keyword>
  <keyword>Sleep</keyword>
  <keyword>Telemedicine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03267537
org study id: 1545864655443n/a
nct id: NCT03267537
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Insomnia is a common medical condition that has a deleterious effect on emotional status,
      health-related quality of life, and has been associated with hospitalizations and all-cause
      mortality. Recently hospitalized patients who are recuperating in their homes would find it
      difficult to return for weekly visits with a clinical psychologist and therefore could
      benefit from the convenience of CBT-I treatment administered in the comfort of their homes
      via the wireless iPAD and video chat software. In patients who are recently discharged from
      the hospital, we wish to assess whether telemedicine-based CBT-I is comparable to
      conventional office-based CBT-I in the efficacy for treating insomnia. Research aiming to
      improve understanding of whether insomnia represents a modifiable risk factor for
      re-hospitalizations in patients who are high utilizers of healthcare services is an important
      area of future research.
Insomnia is a common and distressing medical condition that affects nearly 20% of U.S.
      adults, and persistent (or chronic) insomnia affects nearly 10-15% of U.S. adults. In a
      community-based prospective observational study, preliminary data suggests that insomnia is
      associated with hospitalizations due to cardiovascular, cancer, or any cause over a 4-year
      period. Cognitive Behavioral Therapy for Insomnia (CBT-I) is considered the gold-standard in
      the treatment of insomnia. There are 5 components of CBT-I, sleep restriction therapy,
      stimulus control instructions, relaxation training, cognitive therapy, and sleep hygiene
      education. In an ongoing study of CBT-I in recently hospitalized patients, the investigators
      found a high prevalence of insomnia (80%) and were able to administer CBT-I in the
      participants' home via iPADs with wireless connectivity and secure video-chat software.
      Recently hospitalized patients who are recuperating in their homes would find it difficult to
      return for weekly visits with a clinical psychologist and therefore could benefit from the
      convenience of CBT-I treatment administered in the patient's homes via the wireless iPAD and
      video chat software. The AASM SleepTM platform could conceivably allow performance of CBT-I
      without the added expense of an iPAD. The investigators are proposing to perform a
      non-inferiority trial of telemedicine CBT-I (AASM SleepTM) versus conventional office-based
      CBT-I that is performed in patients with insomnia who have been recently discharged from the
      hospital. The investigators will measure the following outcomes: insomnia severity index
      (primary outcome) and patient satisfaction. In the future, the investigators' program of
      research aims to improve understanding of whether insomnia represents a modifiable risk
      factor for re-hospitalizations in patients who are high utilizers of healthcare services.

      Specific Aim 1: To perform comparative effectiveness research of CBT-I administered by
      telemedicine versus conventional office-based CBT-I on insomnia severity in recently
      hospitalized patients.

      Hypothesis #1: In recently hospitalized patients with insomnia, after six weeks of CBT-I
      treatment, the mean improvement in ISI score among patients treated by telemedicine CBT-I
      (AASM SleepTM) would be no more than 3-points less than that in patients treated by
      conventional office-based CBT-I.

      Specific Aim 2: To perform comparative effectiveness research of CBT-I administered by
      telemedicine versus conventional office-based CBT-I on patient satisfaction.

      Hypothesis #2: In recently hospitalized patients with insomnia, after six weeks of CBT-I
      treatment, the mean improvement in patient satisfaction score (Consumer Assessment of Health
      Plans Survey [CAHPS v4.0] item) among patients treated by telemedicine CBT-I (AASM SleepTM)
      would be no more than 1-point less than that in patients treated by conventional office-based
      CBT-I.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized Controlled Trial
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
masking description: Observers will be blinded to subjects group assignment
measure: Insomnia Severity Index (ISI)
time frame: Baseline and after receiving CBT-I (~6 weeks)
description: A 7-item questionnaire used to assess insomnia severity with a score ranging between 0 to 28. Each questionnaire item addresses an aspect about sleep that is rated by the respondent on a 5-point scale (i.e., 0=no problem & 4=very severe problem) Change in ISI score will be assessed between baseline and following CBT-I treatment over a 6 week period.
measure: Consumer Assessment of Health Plans Survey (CAHPS v4.0) item
time frame: Administered at baseline and at the end of receiving CBT-I (~6 weeks)
description: Health plan member's satisfaction with care on 0 to 10 scale (0 is the "worst " and 10 is the "best health plan possible"). Change in CAHPS score will be measured
measure: Wake After Sleep Onset (WASO)
time frame: Sleep diaries are completed daily and actiwatch is worn continuously during the treatment period (~6 weeks)
description: WASO is defined as the number of minutes spent awake after sleep onset. This is going to be measured by wrist actigraphy and sleep diaries. Change in WASO will be assessed over the intervention period
measure: Sleep Onset Latency (SOL)
time frame: Sleep diaries are completed daily and actiwatch is worn continuously during the treatment period (~6 weeks)
description: SOL is the number of minutes that it takes to fall asleep. This is going to be measured by wrist actigraphy and sleep diaries. Change in SOL will be assessed over the intervention period
measure: Pittsburgh Sleep Quality Index (PSQI)
time frame: Administered at baseline and at the end of receiving CBT-I (~6 weeks)
description: Provides a subjective assessment of sleep quality. Change in PSQI score will be assessed between baseline and 6-week follow-up.
measure: SF-36 Health Survey
time frame: Administered at baseline, at the end of receiving CBT-I (~6 weeks), at 2 weeks following treatment, and at 12 weeks following treatment
description: A 36 item health status assessment tool, which measures general health and quality of life. Change in various dimensions of the SF-36 will be assessed over the 6-week period.
measure: Re-hospitalizations
time frame: Administered at the time of hospital discharge and at the end of receiving CBT-I (~6 weeks)
description: Composite number of hospital readmissions over 6 weeks.
measure: Healthcare utilization
time frame: Administered at the time of hospital discharge and at the end of receiving CBT-I (~6 weeks)
description: Composite number of visits to any of the following locations of healthcare service for care delivery: Emergency room, urgent care, as well as unscheduled and scheduled clinic visits.
measure: Epworth Sleepiness Scale (ESS)
time frame: Administered at baseline and at the end of receiving CBT-I (~6 weeks)
description: A measure of sleepiness. Change in ESS score will be assessed
arm group label: Conventional office-based CBT-I
arm group type: Active Comparator
description: CBT-I will be delivered by a licensed clinical psychologist in weekly sessions lasting up to 1 hour. There will be 6 CBT-I sessions over the course of therapy with the option of an additional 2 treatments if deemed necessary by the clinical psychologist.
arm group label: Telemedicine based CBT-I
arm group type: Experimental
description: The treatment will be the exact same as the active comparator group, with the same clinical psychologist doing the office-based CBT-I, but will be administered through a telemedicine modality
intervention type: Behavioral
intervention name: Telemedicine CBT-I
description: Will be administered in a manner similar to the conventional CBT-I arm except that the patient would not be required to make office visits
arm group label: Telemedicine based CBT-I
intervention type: Behavioral
intervention name: Conventional office-based CBT-I
description: Conventional office-based CBT-I
arm group label: Conventional office-based CBT-I
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sairam Parthasarathy, MD
phone: (520) 626-6109
email: sparthasarathy@deptofmed.arizona.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
citation: Buysse DJ. Insomnia. JAMA. 2013 Feb 20;309(7):706-16. doi: 10.1001/jama.2013.193.
PMID: 23423416
citation: Kyle SD, Morgan K, Espie CA. Insomnia and health-related quality of life. Sleep Med Rev. 2010 Feb;14(1):69-82. doi: 10.1016/j.smrv.2009.07.004. Epub 2009 Dec 4.
PMID: 19962922
citation: Parthasarathy S, Vasquez MM, Halonen M, Bootzin R, Quan SF, Martinez FD, Guerra S. Persistent insomnia is associated with mortality risk. Am J Med. 2015 Mar;128(3):268-75.e2. doi: 10.1016/j.amjmed.2014.10.015. Epub 2014 Oct 16.
PMID: 25447616
citation: Foley DJ, Monjan AA, Brown SL, Simonsick EM, Wallace RB, Blazer DG. Sleep complaints among elderly persons: an epidemiologic study of three communities. Sleep. 1995 Jul;18(6):425-32. doi: 10.1093/sleep/18.6.425.
PMID: 7481413
citation: Althuis MD, Fredman L, Langenberg PW, Magaziner J. The relationship between insomnia and mortality among community-dwelling older women. J Am Geriatr Soc. 1998 Oct;46(10):1270-3. doi: 10.1111/j.1532-5415.1998.tb04544.x.
PMID: 9777910
citation: Newman AB, Spiekerman CF, Enright P, Lefkowitz D, Manolio T, Reynolds CF, Robbins J. Daytime sleepiness predicts mortality and cardiovascular disease in older adults. The Cardiovascular Health Study Research Group. J Am Geriatr Soc. 2000 Feb;48(2):115-23. doi: 10.1111/j.1532-5415.2000.tb03901.x.
PMID: 10682939
citation: Rockwood K, Davis HS, Merry HR, MacKnight C, McDowell I. Sleep disturbances and mortality: results from the Canadian Study of Health and Aging. J Am Geriatr Soc. 2001 May;49(5):639-41. doi: 10.1046/j.1532-5415.2001.49125.x.
PMID: 11380758
citation: Nilsson PM, Nilsson JA, Hedblad B, Berglund G. Sleep disturbance in association with elevated pulse rate for prediction of mortality--consequences of mental strain? J Intern Med. 2001 Dec;250(6):521-9. doi: 10.1046/j.1365-2796.2001.00913.x.
PMID: 11902821
citation: Mallon L, Broman JE, Hetta J. Sleep complaints predict coronary artery disease mortality in males: a 12-year follow-up study of a middle-aged Swedish population. J Intern Med. 2002 Mar;251(3):207-16. doi: 10.1046/j.1365-2796.2002.00941.x.
PMID: 11886479
citation: Suzuki E, Yorifuji T, Ueshima K, Takao S, Sugiyama M, Ohta T, Ishikawa-Takata K, Doi H. Sleep duration, sleep quality and cardiovascular disease mortality among the elderly: a population-based cohort study. Prev Med. 2009 Aug-Sep;49(2-3):135-41. doi: 10.1016/j.ypmed.2009.06.016. Epub 2009 Jun 30.
PMID: 19573557
citation: Rod NH, Vahtera J, Westerlund H, Kivimaki M, Zins M, Goldberg M, Lange T. Sleep disturbances and cause-specific mortality: Results from the GAZEL cohort study. Am J Epidemiol. 2011 Feb 1;173(3):300-9. doi: 10.1093/aje/kwq371. Epub 2010 Dec 30.
PMID: 21193534
citation: Almeida OP, Alfonso H, Yeap BB, Hankey G, Flicker L. Complaints of difficulty to fall asleep increase the risk of depression in later life: the health in men study. J Affect Disord. 2011 Nov;134(1-3):208-16. doi: 10.1016/j.jad.2011.05.045. Epub 2011 Jun 15.
PMID: 21680026
citation: Eaker ED, Pinsky J, Castelli WP. Myocardial infarction and coronary death among women: psychosocial predictors from a 20-year follow-up of women in the Framingham Study. Am J Epidemiol. 1992 Apr 15;135(8):854-64. doi: 10.1093/oxfordjournals.aje.a116381.
PMID: 1585898
citation: Vgontzas AN, Liao D, Pejovic S, Calhoun S, Karataraki M, Basta M, Fernandez-Mendoza J, Bixler EO. Insomnia with short sleep duration and mortality: the Penn State cohort. Sleep. 2010 Sep;33(9):1159-64. doi: 10.1093/sleep/33.9.1159.
PMID: 20857861
citation: Li Y, Zhang X, Winkelman JW, Redline S, Hu FB, Stampfer M, Ma J, Gao X. Association between insomnia symptoms and mortality: a prospective study of U.S. men. Circulation. 2014 Feb 18;129(7):737-46. doi: 10.1161/CIRCULATIONAHA.113.004500. Epub 2013 Nov 13.
PMID: 24226807
citation: Haynes PL, Parthasarathy S, Kersh B, Bootzin RR. Examination of insomnia and insomnia treatment in psychiatric inpatients. Int J Ment Health Nurs. 2011 Apr;20(2):130-6. doi: 10.1111/j.1447-0349.2010.00711.x.
PMID: 21371228
citation: Morin CM, Belleville G, Belanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8. doi: 10.1093/sleep/34.5.601.
PMID: 21532953
citation: Schmittdiel J, Mosen DM, Glasgow RE, Hibbard J, Remmers C, Bellows J. Patient Assessment of Chronic Illness Care (PACIC) and improved patient-centered outcomes for chronic conditions. J Gen Intern Med. 2008 Jan;23(1):77-80. doi: 10.1007/s11606-007-0452-5. Epub 2007 Nov 21.
PMID: 18030539
citation: Michelson D, Snyder E, Paradis E, Chengan-Liu M, Snavely DB, Hutzelmann J, Walsh JK, Krystal AD, Benca RM, Cohn M, Lines C, Roth T, Herring WJ. Safety and efficacy of suvorexant during 1-year treatment of insomnia with subsequent abrupt treatment discontinuation: a phase 3 randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2014 May;13(5):461-71. doi: 10.1016/S1474-4422(14)70053-5. Epub 2014 Mar 27.
PMID: 24680372
citation: Morin CM, Vallieres A, Guay B, Ivers H, Savard J, Merette C, Bastien C, Baillargeon L. Cognitive behavioral therapy, singly and combined with medication, for persistent insomnia: a randomized controlled trial. JAMA. 2009 May 20;301(19):2005-15. doi: 10.1001/jama.2009.682.
PMID: 19454639
citation: Buysse DJ, Ancoli-Israel S, Edinger JD, Lichstein KL, Morin CM. Recommendations for a standard research assessment of insomnia. Sleep. 2006 Sep;29(9):1155-73. doi: 10.1093/sleep/29.9.1155. Erratum In: Sleep. 2006 Nov 1;29(11):1380.
PMID: 17040003
responsible party type: Principal Investigator
investigator affiliation: University of Arizona
investigator full name: Sairam Parthasarathy
investigator title: Professor of Medicine
mesh term: Sleep Initiation and Maintenance Disorders
sharing ipd: No