<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/NCT01699139</url>
  </required_header>
  <id_info>
    <org_study_id>NSC101-2314-B-182A-111</org_study_id>
    <nct_id>NCT01699139</nct_id>
  </id_info>
  <brief_title>The Effect of Positional Device on the Obstructive Sleep Apnea in Patients With Ischemic Stroke</brief_title>
  <official_title>The Effect of Positional Device on the Obstructive Sleep Apnea in Patients With Ischemic Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Science Council, Taiwan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chang Gung Memorial Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Supine positioning was reported to increase upper airway collapsibility, apnea frequency and&#xD;
      duration. Positional therapy, designed to minimize supine sleep, was reported to be&#xD;
      beneficial in the general sleep apnea population. As supine sleep is very common in stroke&#xD;
      patients, positional therapy might also have therapeutic effects. Given differences between&#xD;
      stroke patients with sleep apnea and the general sleep apnea patient, such as rolling&#xD;
      ability, body mass index and daytime sleepiness, positional therapy results in the general&#xD;
      population may not be applicable to the stroke patient.&#xD;
&#xD;
      The effects of positional therapy in ischemic stroke patients with OSA have not been&#xD;
      well-investigated. We therefore performed a pilot randomized, controlled, cross-over study to&#xD;
      test the following hypotheses: (1) positional therapy reduces the amount of nocturnal supine&#xD;
      positioning in patients with subacute ischemic stroke, and (2) severity of sleep apnea&#xD;
      improves, as reflected by apnea-hypopnea index (AHI), during positional therapy. The&#xD;
      tolerability of positional therapy over a 3-month period in patients with ischemic stroke was&#xD;
      also evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Phase 1:&#xD;
&#xD;
      In the first phase, a randomized, controlled, two-period cross-over study design (AB/BA) was&#xD;
      used with no washout period. After an acclimatization period (3 days), during which the&#xD;
      compliance of the Positional Device was monitored, each patient was randomized into either&#xD;
      Group I (sequence AB) or Group II (sequence BA). After commencement of treatment, the outcome&#xD;
      measures were repeated on the last day of each treatment period. On the control night (B),&#xD;
      subjects used the lumbar corset and were positioned ad lib.&#xD;
&#xD;
      Phase 2:&#xD;
&#xD;
      In the second phase of the study which began immediately after attainment of the first phase,&#xD;
      subjects were randomized on a 1:1 basis, in a parallel group design, to 3 months of&#xD;
      positional devices or sleeping ad lib. At 3 months later all subjects were interviewed face&#xD;
      to face to determine the Barthel index and the Patient Health Questionnaire 9-item depression&#xD;
      scale. Subjects in the positional devices group were also evaluated about devices adherence&#xD;
      using the following questions: use of the device all nights, most nights, some nights, or no&#xD;
      nights.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in apnea-hypopnea index (AHI)</measure>
    <time_frame>change from baseline in apnea-hypopnea index at 1 week and change from baseline in apnea-hypopnea index at 2 weeks</time_frame>
    <description>The AHI was defined as the average number of apneas and hypopneas per hour of sleep.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Augmentation Index</measure>
    <time_frame>Change from baseline in Augmentation Index at 1 week and change from baseline in Augmentation Index at 2 weeks</time_frame>
    <description>The shape of the pressure waveform of an artery provides a measure of arterial stiffness and can be assessed by the technique of pulse wave analysis. Radial artery pulse waveforms were recorded using a pressure tonometer and dedicated software as previously described (SphygmoCor; At-Cor Medical, Sydney, Australia). Augmentation index, which quantifies augmentation of central aortic pressure (due to the reflected component of the pulse pressure waveform) and typically increases with age as the arteries become less compliant, is then calculated as the difference between the second (P2) and first systolic peak pressure (P1), expressed as percentage of the central pulse pressure (PP):&#xD;
Augmentation index (%) = ((P2-P1)/PP)×100(1)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in pulse wave velocity</measure>
    <time_frame>Change from baseline in pulse wave velocity at 1 week and change from baseline in pulse wave velocity at 2 weeks</time_frame>
    <description>The SphygmoCor System measures the pulse wave velocity of the blood pressure waveform travelling between any two arterial sites that can be measured non-invasively. The velocity of the blood pressure pulse waveform is dependent on the stiffness of the artery along which the pulse is travelling. Measurements are performed by recording pressure waveforms at the carotid artery followed by the femoral artery, with an ECG signal recorded simultaneously.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 24-hour blood pressure profile</measure>
    <time_frame>Change from baseline in 24-hour blood pressure profile at 1 week and change from baseline in 24-hour blood pressure profile at 2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Patient Health Questionnaire 9-item depression scale (PHQ-9)</measure>
    <time_frame>Change from baseline in the PHQ-9 at 1 week, change from baseline in the PHQ-9 at 2 weeks and change from baseline in the PHQ-9 at 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the percentage of nocturnal supine positioning during sleep</measure>
    <time_frame>Change from baseline in the percentage of nocturnal supine positioning at 1 week and change from baseline in the percentage of nocturnal supine positioning at 2 weeks</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Barthel index</measure>
    <time_frame>Change from baseline in Barthel index at 1 week, change from baseline in Barthel index at 2 weeks and change from baseline in Barthel index at 12 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Tolerability of the positional devices</measure>
    <time_frame>12 weeks after wearing the positional devices</time_frame>
    <description>Participants were asked to wear the positional devices for 3 months during sleep and were queried about devices adherence at the end of the study using the following questions: use of the device all nights, most nights, some nights, or no nights.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Sleep Apnea, Obstructive</condition>
  <condition>Brain Ischemia</condition>
  <arm_group>
    <arm_group_label>positional device</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>lumbar corset</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>positional device</intervention_name>
    <description>Avoidance of supine positioning was achieved by use of the commercially available ZZoma Positional Device, which is the FDA cleared class II positional medical device. The device is 12 x 5.5 x 4 inches in size and made of lightweight semi-rigid synthetic foam. It is contained in the nylon material with an associated Velcro belt. Zzoma is a positioner worn around the upper torso to restrict patient movement from side to supine.</description>
    <arm_group_label>positional device</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>lumbar corset</intervention_name>
    <description>A lumbar (abdominal) binder is made of an elastic fabric with Velcro closure. Subjects wore the prefabricated lumbar corset during sleep and were positioned ad lib.</description>
    <arm_group_label>lumbar corset</arm_group_label>
    <other_name>brand name: HEAVY-DUTY WAIST BINDER</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with ischemic stroke (&gt; 1month, within 12 months) and moderate-to-severe OSA&#xD;
             (AHI&gt;15) who could wear the positional devices not interfering with his/her sleep.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unclear consciousness&#xD;
&#xD;
          -  unstable vital sign or neurologic sign&#xD;
&#xD;
          -  unstable medical conditions&#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_official>
    <last_name>Chungyao Chen, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chang Gung Memorial Hospital, Keelung</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chang Gung Memorial Hospital, Keelung</name>
      <address>
        <city>Keelung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>September 27, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>February 9, 2015</last_update_submitted>
  <last_update_submitted_qc>February 9, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 10, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>supine position</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apnea</mesh_term>
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
    <mesh_term>Brain Ischemia</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <!-- 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/NCT01699139
org study id: NSC101-2314-B-182A-111
nct id: NCT01699139
lead sponsor: 
collaborator: 
has dmc: Yes
Supine positioning was reported to increase upper airway collapsibility, apnea frequency and
      duration. Positional therapy, designed to minimize supine sleep, was reported to be
      beneficial in the general sleep apnea population. As supine sleep is very common in stroke
      patients, positional therapy might also have therapeutic effects. Given differences between
      stroke patients with sleep apnea and the general sleep apnea patient, such as rolling
      ability, body mass index and daytime sleepiness, positional therapy results in the general
      population may not be applicable to the stroke patient.

      The effects of positional therapy in ischemic stroke patients with OSA have not been
      well-investigated. We therefore performed a pilot randomized, controlled, cross-over study to
      test the following hypotheses: (1) positional therapy reduces the amount of nocturnal supine
      positioning in patients with subacute ischemic stroke, and (2) severity of sleep apnea
      improves, as reflected by apnea-hypopnea index (AHI), during positional therapy. The
      tolerability of positional therapy over a 3-month period in patients with ischemic stroke was
      also evaluated.
Phase 1:

      In the first phase, a randomized, controlled, two-period cross-over study design (AB/BA) was
      used with no washout period. After an acclimatization period (3 days), during which the
      compliance of the Positional Device was monitored, each patient was randomized into either
      Group I (sequence AB) or Group II (sequence BA). After commencement of treatment, the outcome
      measures were repeated on the last day of each treatment period. On the control night (B),
      subjects used the lumbar corset and were positioned ad lib.

      Phase 2:

      In the second phase of the study which began immediately after attainment of the first phase,
      subjects were randomized on a 1:1 basis, in a parallel group design, to 3 months of
      positional devices or sleeping ad lib. At 3 months later all subjects were interviewed face
      to face to determine the Barthel index and the Patient Health Questionnaire 9-item depression
      scale. Subjects in the positional devices group were also evaluated about devices adherence
      using the following questions: use of the device all nights, most nights, some nights, or no
      nights.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in apnea-hypopnea index (AHI)
time frame: change from baseline in apnea-hypopnea index at 1 week and change from baseline in apnea-hypopnea index at 2 weeks
description: The AHI was defined as the average number of apneas and hypopneas per hour of sleep.
measure: Change in Augmentation Index
time frame: Change from baseline in Augmentation Index at 1 week and change from baseline in Augmentation Index at 2 weeks
description: The shape of the pressure waveform of an artery provides a measure of arterial stiffness and can be assessed by the technique of pulse wave analysis. Radial artery pulse waveforms were recorded using a pressure tonometer and dedicated software as previously described (SphygmoCor; At-Cor Medical, Sydney, Australia). Augmentation index, which quantifies augmentation of central aortic pressure (due to the reflected component of the pulse pressure waveform) and typically increases with age as the arteries become less compliant, is then calculated as the difference between the second (P2) and first systolic peak pressure (P1), expressed as percentage of the central pulse pressure (PP):
Augmentation index (%) = ((P2-P1)/PP)×100(1)
measure: Change in pulse wave velocity
time frame: Change from baseline in pulse wave velocity at 1 week and change from baseline in pulse wave velocity at 2 weeks
description: The SphygmoCor System measures the pulse wave velocity of the blood pressure waveform travelling between any two arterial sites that can be measured non-invasively. The velocity of the blood pressure pulse waveform is dependent on the stiffness of the artery along which the pulse is travelling. Measurements are performed by recording pressure waveforms at the carotid artery followed by the femoral artery, with an ECG signal recorded simultaneously.
measure: Change in 24-hour blood pressure profile
time frame: Change from baseline in 24-hour blood pressure profile at 1 week and change from baseline in 24-hour blood pressure profile at 2 weeks
measure: Change in the Patient Health Questionnaire 9-item depression scale (PHQ-9)
time frame: Change from baseline in the PHQ-9 at 1 week, change from baseline in the PHQ-9 at 2 weeks and change from baseline in the PHQ-9 at 12 weeks
measure: Change in the percentage of nocturnal supine positioning during sleep
time frame: Change from baseline in the percentage of nocturnal supine positioning at 1 week and change from baseline in the percentage of nocturnal supine positioning at 2 weeks
measure: Change in Barthel index
time frame: Change from baseline in Barthel index at 1 week, change from baseline in Barthel index at 2 weeks and change from baseline in Barthel index at 12 weeks
measure: Tolerability of the positional devices
time frame: 12 weeks after wearing the positional devices
description: Participants were asked to wear the positional devices for 3 months during sleep and were queried about devices adherence at the end of the study using the following questions: use of the device all nights, most nights, some nights, or no nights.
arm group label: positional device
arm group type: Active Comparator
arm group label: lumbar corset
arm group type: Sham Comparator
intervention type: Device
intervention name: positional device
description: Avoidance of supine positioning was achieved by use of the commercially available ZZoma Positional Device, which is the FDA cleared class II positional medical device. The device is 12 x 5.5 x 4 inches in size and made of lightweight semi-rigid synthetic foam. It is contained in the nylon material with an associated Velcro belt. Zzoma is a positioner worn around the upper torso to restrict patient movement from side to supine.
arm group label: positional device
intervention type: Device
intervention name: lumbar corset
description: A lumbar (abdominal) binder is made of an elastic fabric with Velcro closure. Subjects wore the prefabricated lumbar corset during sleep and were positioned ad lib.
arm group label: lumbar corset
other name: brand name: HEAVY-DUTY WAIST BINDER
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Chungyao Chen, M.D.
role: Principal Investigator
affiliation: Chang Gung Memorial Hospital, Keelung
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
mesh term: Ischemic Stroke
mesh term: Brain Ischemia
mesh term: Ischemia