Obstructive Sleep ApneaNCT01786291
PAP Therapy Sleep Apnea and Exercise
An observational study of Obstructive Sleep Apnea, run by University of Gaziantep at 1 site in Turkey (Türkiye).
Trial summary
Positive airway pressure (PAP) therapy is generally offered to patients with obstructive sleep apnea. The investigators suggest that beneficial effects of PAP therapy is by preventing apneas and therefore reducing cardiac and pulmonary morbidities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2010to Jul 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients newly diasgnosed with obstructive sleep apnea in whom CPAP therapy was indicated
Who may be able to join
- obstructive sleep apnea diagnosed by polysomnography
- CPAP therapy indicated
Who cannot join
- obstructive or restrictive lung disease
- cardiac failure
- acute coronary syndrome
- inability to cycle
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Gaziantep, Faculty of Medicine, Dept. of Pulmonary Diseases
Gaziantep, 27310
About this study
Official title: Effects of Positive Airway Pressure Therapy on Exercise Parameters in Obstructive Sleep Apnea
Positive airway pressure (PAP) therapy is generally offered to patients with obstructive sleep apnea. The investigators suggest that beneficial effects of PAP therapy is by preventing apneas and therefore reducing cardiac and pulmonary morbidities. The investigators sought to verify this by assessing cardiac and pulmonary function during exercise.
- Conditions
- Obstructive Sleep Apnea
- Keywords
- obstructive sleep apnea, continuous positive airway pressure, cardiopulmonary exercise test, VE/VCO2
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CPAP compliant | CPAP (continuous positive airway pressure) compliant patients | |
| CPAP non-compliant | patients who did not use CPAP therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
peak oxygen uptake
Measured: 30-60 days
Secondary outcomes (1)
ventilatory equivalent for carbon dioxide at anaerobic threshold
Measured: 30-60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study startMay 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, meral uyar, University of Gaziantep
- Investigators
- Meral Uyar, Assoc Prof, Principal investigator, University of GaziantepNazan Bayram, Assis Prof, Principal investigator, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01786291
- Sponsor's protocol ID
- uyku-cpet-1
- Status last verified
- Feb 2013
- First submitted
- 5 Feb 2013
- Last updated
- 7 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Positive Airway Pressure Therapy on Exercise Parameters in Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT01786291
- Acronym / sponsor ID
- uyku-cpet-1
- Conditions
- Obstructive Sleep Apnea
- Keywords
- obstructive sleep apnea, continuous positive airway pressure, cardiopulmonary exercise test, VE/VCO2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 7 Feb 2013 (estimated)
- 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.
Positive airway pressure (PAP) therapy is generally offered to patients with obstructive sleep apnea. The investigators suggest that beneficial effects of PAP therapy is by preventing apneas and therefore reducing cardiac and pulmonary morbidities. The investigators sought to verify this by assessing cardiac and pulmonary function during exercise.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP compliant | – | –CPAP (continuous positive airway pressure) compliant patients |
| CPAP non-compliant | – | –patients who did not use CPAP therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients newly diasgnosed with obstructive sleep apnea in whom CPAP therapy was indicated
Key inclusion criteria (2 listed)
- obstructive sleep apnea diagnosed by polysomnography
- CPAP therapy indicated
Key exclusion criteria (4 listed)
- obstructive or restrictive lung disease
- cardiac failure
- acute coronary syndrome
- inability to cycle
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
peak oxygen uptake
Time frame: 30-60 days
1 secondary outcome
ventilatory equivalent for carbon dioxide at anaerobic threshold
Time frame: 30-60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2013.
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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.
Meral Uyar, Assoc Prof principal investigator
University of Gaziantep
Nazan Bayram, Assis Prof principal investigator
University of Gaziantep
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 University of Gaziantep at 1 site in Turkey (Türkiye).
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 7 Feb 2013. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
peak oxygen uptake (time frame: 30-60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Feb 2013.