<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/NCT03300700</url>
  </required_header>
  <id_info>
    <org_study_id>CETIPWOSA</org_study_id>
    <nct_id>NCT03300700</nct_id>
  </id_info>
  <brief_title>Cardiopulmonary Exercise Test in Patient With Obstructive Sleep Apnea</brief_title>
  <official_title>Cardiopulmonary Exercise Test in Patient With Obstructive Sleep Apnea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</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>
      Obstructive sleep apnea (OSA) can be described as a condition characterized by repetitive&#xD;
      obstruction of the upper airway resulting in oxygen desaturation and awakening from sleep,&#xD;
      loud snoring, and increased daytime sleepiness . Many studies have shown that a link exists&#xD;
      between OSA and cardiovascular disease, chronic heart failure ischemia, hypertension,&#xD;
      obesity, and impaired glucose tolerance . A number of factors are likely to play role in&#xD;
      development of clinical OSA syndrome (OSAS) ranging from upper airway anatomy to central&#xD;
      respiratory control mechanisms. The pathophysiology of OSA is unclear and complex. Several&#xD;
      previous studies have explored pulmonary function in the OSAS patients Interestingly, OSAS&#xD;
      has been found to be highly correlated with lower airway obstruction, although it is&#xD;
      originally defined as an upper airway disease&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      American Sleep Apnea Association considers exercise as a non-pharmacological treatment&#xD;
      modality of sleep disorders . Theoretical reviews and hypotheses on the effects of exercise&#xD;
      in OSA have suggested thermoregulatory, metabolic, and biochemical mechanisms although&#xD;
      clinical trials on the topic are inadequate .&#xD;
&#xD;
      Cardiopulmonary exercise testing (CPET) is used as a stress test to evaluate cardiac,&#xD;
      pulmonary, and muscle function. It has also been used to differentiate whether the etiology&#xD;
      of impairment of the ca. rdiopulmonary exercise test is cardiac, pulmonary or muscle&#xD;
      dysfunction In otherwise healthy subjects, exercise limitation is due to heart disease.&#xD;
      Patients with OSAS are frequently overweight and may exhibit lung function abnormalities&#xD;
      related to their weight. These include a decrease in the functional residual capacity (FRC)&#xD;
      due mainly to a decrease in the expiratory reserve volume (ERV) and a decrease in compliance&#xD;
      of the respiratory system. These functional abnormalities cause an increase in the energy&#xD;
      cost of breathing. In addition, increased body mass is associated with greater metabolic&#xD;
      energy requirements during muscular exercise, resulting in further ventilatory stress. There&#xD;
      are reports demonstrating that there are discriminating measurements during exercise in&#xD;
      obesity, including a high O2 cost to perform external work, and upward displacement of the&#xD;
      VO2 -WR relationship OSAS patients have daytime hypersomnolence, decreased daily activity and&#xD;
      tissue hypoxemia which may further impair muscle function and decrease exercise fitness.&#xD;
      Recently, Peppard and Young (2004) found that, independent of body habitus, lack of exercise&#xD;
      was associated with increased severity of sleep-disordered breathing measurements during&#xD;
      exercise in obesity, including a high O2 cost to perform external work, and upward&#xD;
      displacement of the VO2 -WR relationship. OSAS patients have daytime hypersomnolence,&#xD;
      decreased daily activity and tissue hypoxemia which may further impair muscle function and&#xD;
      decrease exercise fitness. Recently, Peppard and Young (2004) found that, independent of body&#xD;
      habitus, lack of exercise was associated with increased severity of sleep-disordered&#xD;
      breathing&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 1, 2017</start_date>
  <completion_date type="Anticipated">March 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Ventilatory parameters of cardiopulmonary exercise test</measure>
    <time_frame>30 minutes</time_frame>
    <description>End tidal Pco2 and Po2 will be measured in patients with obstructive sleep apnea</description>
  </primary_outcome>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The study will be conducted as prospective study including 50 patients either admitted at&#xD;
        our chest department or presented at our out patient clinic and diagnosed as Obstructive&#xD;
        sleep apnea according to clinical picture and sleep study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stable OSA patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiovascular diseases .&#xD;
&#xD;
          -  Orthopedic or neurological conditions affecting the ability of exercise.&#xD;
&#xD;
          -  Patients with previous lung resection or malignancies.&#xD;
&#xD;
          -  Patients with liver cell failure, renal failure.&#xD;
&#xD;
          -  Muscloskeletal disease.&#xD;
&#xD;
          -  Other chronic chest disease eg, ILD.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Raafat T El-Sokkary, prof</last_name>
    <role>Study Director</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Asmaa G Nafady, residant</last_name>
    <phone>00201015826887</phone>
    <email>asmaanafady5922@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ahmed M Azoz, Dr</last_name>
    <phone>00201002163907</phone>
    <email>Ahmed_80metwally@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Assiut University Hospital</name>
      <address>
        <city>Assiut</city>
        <zip>Assiut,Egypt,Assiut university</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>McNamara SG, Grunstein RR, Sullivan CE. Obstructive sleep apnoea. Thorax. 1993 Jul;48(7):754-64. doi: 10.1136/thx.48.7.754. No abstract available.</citation>
    <PMID>8153927</PMID>
  </reference>
  <reference>
    <citation>Parish JM, Somers VK. Obstructive sleep apnea and cardiovascular disease. Mayo Clin Proc. 2004 Aug;79(8):1036-46. doi: 10.4065/79.8.1036.</citation>
    <PMID>15301332</PMID>
  </reference>
  <reference>
    <citation>Levinson PD, McGarvey ST, Carlisle CC, Eveloff SE, Herbert PN, Millman RP. Adiposity and cardiovascular risk factors in men with obstructive sleep apnea. Chest. 1993 May;103(5):1336-42. doi: 10.1378/chest.103.5.1336.</citation>
    <PMID>8486007</PMID>
  </reference>
  <reference>
    <citation>Ozturk L, Metin G, Cuhadaroglu C, Utkusavas A, Tutluoglu B. FEF(25-75)/FVC measurements and extrathoracic airway obstruction in obstructive sleep apnea patients. Sleep Breath. 2005 Mar;9(1):33-8. doi: 10.1007/s11325-005-0006-1.</citation>
    <PMID>15785919</PMID>
  </reference>
  <reference>
    <citation>Vgontzas AN, Bixler EO, Chrousos GP. Sleep apnea is a manifestation of the metabolic syndrome. Sleep Med Rev. 2005 Jun;9(3):211-24. doi: 10.1016/j.smrv.2005.01.006.</citation>
    <PMID>15893251</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>September 28, 2017</last_update_submitted>
  <last_update_submitted_qc>September 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Asmaa Nafady</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <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>
  </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/NCT03300700
org study id: CETIPWOSA
nct id: NCT03300700
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Obstructive sleep apnea (OSA) can be described as a condition characterized by repetitive
      obstruction of the upper airway resulting in oxygen desaturation and awakening from sleep,
      loud snoring, and increased daytime sleepiness . Many studies have shown that a link exists
      between OSA and cardiovascular disease, chronic heart failure ischemia, hypertension,
      obesity, and impaired glucose tolerance . A number of factors are likely to play role in
      development of clinical OSA syndrome (OSAS) ranging from upper airway anatomy to central
      respiratory control mechanisms. The pathophysiology of OSA is unclear and complex. Several
      previous studies have explored pulmonary function in the OSAS patients Interestingly, OSAS
      has been found to be highly correlated with lower airway obstruction, although it is
      originally defined as an upper airway disease
American Sleep Apnea Association considers exercise as a non-pharmacological treatment
      modality of sleep disorders . Theoretical reviews and hypotheses on the effects of exercise
      in OSA have suggested thermoregulatory, metabolic, and biochemical mechanisms although
      clinical trials on the topic are inadequate .

      Cardiopulmonary exercise testing (CPET) is used as a stress test to evaluate cardiac,
      pulmonary, and muscle function. It has also been used to differentiate whether the etiology
      of impairment of the ca. rdiopulmonary exercise test is cardiac, pulmonary or muscle
      dysfunction In otherwise healthy subjects, exercise limitation is due to heart disease.
      Patients with OSAS are frequently overweight and may exhibit lung function abnormalities
      related to their weight. These include a decrease in the functional residual capacity (FRC)
      due mainly to a decrease in the expiratory reserve volume (ERV) and a decrease in compliance
      of the respiratory system. These functional abnormalities cause an increase in the energy
      cost of breathing. In addition, increased body mass is associated with greater metabolic
      energy requirements during muscular exercise, resulting in further ventilatory stress. There
      are reports demonstrating that there are discriminating measurements during exercise in
      obesity, including a high O2 cost to perform external work, and upward displacement of the
      VO2 -WR relationship OSAS patients have daytime hypersomnolence, decreased daily activity and
      tissue hypoxemia which may further impair muscle function and decrease exercise fitness.
      Recently, Peppard and Young (2004) found that, independent of body habitus, lack of exercise
      was associated with increased severity of sleep-disordered breathing measurements during
      exercise in obesity, including a high O2 cost to perform external work, and upward
      displacement of the VO2 -WR relationship. OSAS patients have daytime hypersomnolence,
      decreased daily activity and tissue hypoxemia which may further impair muscle function and
      decrease exercise fitness. Recently, Peppard and Young (2004) found that, independent of body
      habitus, lack of exercise was associated with increased severity of sleep-disordered
      breathing
observational model: Cohort
time perspective: Prospective
measure: Ventilatory parameters of cardiopulmonary exercise test
time frame: 30 minutes
description: End tidal Pco2 and Po2 will be measured in patients with obstructive sleep apnea
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Raafat T El-Sokkary, prof
role: Study Director
affiliation: Assiut University
last name: Asmaa G Nafady, residant
phone: 00201015826887
email: asmaanafady5922@yahoo.com
last name: Ahmed M Azoz, Dr
phone: 00201002163907
email: Ahmed_80metwally@yahoo.com
facility: 
country: Egypt
citation: McNamara SG, Grunstein RR, Sullivan CE. Obstructive sleep apnoea. Thorax. 1993 Jul;48(7):754-64. doi: 10.1136/thx.48.7.754. No abstract available.
PMID: 8153927
citation: Parish JM, Somers VK. Obstructive sleep apnea and cardiovascular disease. Mayo Clin Proc. 2004 Aug;79(8):1036-46. doi: 10.4065/79.8.1036.
PMID: 15301332
citation: Levinson PD, McGarvey ST, Carlisle CC, Eveloff SE, Herbert PN, Millman RP. Adiposity and cardiovascular risk factors in men with obstructive sleep apnea. Chest. 1993 May;103(5):1336-42. doi: 10.1378/chest.103.5.1336.
PMID: 8486007
citation: Ozturk L, Metin G, Cuhadaroglu C, Utkusavas A, Tutluoglu B. FEF(25-75)/FVC measurements and extrathoracic airway obstruction in obstructive sleep apnea patients. Sleep Breath. 2005 Mar;9(1):33-8. doi: 10.1007/s11325-005-0006-1.
PMID: 15785919
citation: Vgontzas AN, Bixler EO, Chrousos GP. Sleep apnea is a manifestation of the metabolic syndrome. Sleep Med Rev. 2005 Jun;9(3):211-24. doi: 10.1016/j.smrv.2005.01.006.
PMID: 15893251
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Asmaa Nafady
investigator title: Principal Investigator
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
sharing ipd: No