Obstructive Sleep ApneaNCT03300700
Cardiopulmonary Exercise Test in Patient With Obstructive Sleep Apnea
An observational study of Obstructive Sleep Apnea, run by Assiut University at 1 site in Egypt.
Trial summary
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 . Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2017to 1 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will be conducted as prospective study including 50 patients either admitted at our chest department or presented at our out patient clinic and diagnosed as Obstructive sleep apnea according to clinical picture and sleep study.
Who may be able to join
- Stable OSA patients
Who cannot join
- Cardiovascular diseases .
- Orthopedic or neurological conditions affecting the ability of exercise.
- Patients with previous lung resection or malignancies.
- Patients with liver cell failure, renal failure.
- Muscloskeletal disease.
- Other chronic chest disease eg, ILD.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the detailed description
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
- Conditions
- Obstructive Sleep Apnea
- Medical subject headings
- Sleep Apnea, Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilatory parameters of cardiopulmonary exercise test
End tidal Pco2 and Po2 will be measured in patients with obstructive sleep apnea
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start1 Oct 2017 (estimated)
- Primary completion1 Sep 2018 (estimated)
- Study completion1 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Nafady, Assiut University
- Investigators
- Raafat T El-Sokkary, prof, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03300700
- Sponsor's protocol ID
- CETIPWOSA
- Status last verified
- Sep 2017
- First submitted
- 29 Aug 2017
- Last updated
- 3 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 8153927Parish JM, Somers VK. Obstructive sleep apnea and cardiovascular disease. Mayo Clin Proc. 2004 Aug;79(8):1036-46. doi: 10.4065/79.8.1036.
PubMed 15301332Levinson 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.
PubMed 8486007Ozturk 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.
PubMed 15785919Vgontzas 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.
PubMed 15893251
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiopulmonary Exercise Test in Patient With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT03300700
- Acronym / sponsor ID
- CETIPWOSA
- Conditions
- Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2017 (estimated)
- Primary completion
- 1 Sep 2018 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 3 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be conducted as prospective study including 50 patients either admitted at our chest department or presented at our out patient clinic and diagnosed as Obstructive sleep apnea according to clinical picture and sleep study.
Key inclusion criteria (1 listed)
- Stable OSA patients
Key exclusion criteria (6 listed)
- Cardiovascular diseases .
- Orthopedic or neurological conditions affecting the ability of exercise.
- Patients with previous lung resection or malignancies.
- Patients with liver cell failure, renal failure.
- Muscloskeletal disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ventilatory parameters of cardiopulmonary exercise test
Time frame: 30 minutes
End tidal Pco2 and Po2 will be measured in patients with obstructive sleep apnea
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2017.
- Background: PubMed 8153927McNamara 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.
- Background: PubMed 15301332Parish JM, Somers VK. Obstructive sleep apnea and cardiovascular disease. Mayo Clin Proc. 2004 Aug;79(8):1036-46. doi: 10.4065/79.8.1036.
- Background: PubMed 8486007Levinson 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.
- Background: PubMed 15785919Ozturk 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.
- Background: PubMed 15893251Vgontzas 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raafat T El-Sokkary, prof study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asmaa G Nafady, residant (00201015826887, asmaanafady5922@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilatory parameters of cardiopulmonary exercise test (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03300700, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2017.