OverweightOSANCT01573676
The Influence of Bariatric Surgery on Patients With Obstructive Sleep Apnea (OSA)
An observational study of Overweight and Obstructive Sleep Apnea, run by Hillel Yaffe Medical Center.
Trial summary
Obesity is a very important risk-factor in obstructive sleep apnea (OSA) and other sleep breathing disorders in patients with extreme BMI. Candidates for bariatric surgery have a high OSA prevalence, ranging from 60-83%. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Overweight, Obstructive Sleep Apnea
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- May 2012to Dec 2013
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: both males and females
Who may be able to join
- All candidates for bariatric surgery over 18 yrs of age
Who cannot join
- Patients that underwent any OSA surgery in the past
- Patient had any bariatric surgery in the past
- Patients with COPD
- Patients with CHD
- Patients who have / had cancer that received chemotherapy or radiotherapy
About this study
Obesity is a very important risk-factor in obstructive sleep apnea (OSA) and other sleep breathing disorders in patients with extreme BMI.
Candidates for bariatric surgery have a high OSA prevalence, ranging from 60-83%. The characteristics of patients with sleep apnea that were evaluated for bariatric surgery and had a full overnight polysomnography (PSG) screening for OSA were described and it was found that a very high prevalence (77.2%) for OSA in all subjects evaluated, regardless of pre-operative risk for OSA. A post-bariatric surgery PSG was not a part of this study.
The investigators would like to demonstrate the impact of bariatric surgery on OSA as a function of time.
- Conditions
- Overweight, Obstructive Sleep Apnea
- Keywords
- bariatric surgery, sleep apnea, overweight
- Medical subject headings
- Overweight, Sleep Apnea, Obstructive, Sleep Apnea Syndromes
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 |
|---|---|---|
| Bariatric surgery patients | Candidates for bariatric surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in RDI after bariatric surgery
Improvement will measured by polysonography
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2012 (estimated)
- Study startMay 2012
- Primary completionJul 2012 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01573676
- Sponsor's protocol ID
- 0048-11-HYMC
- Acronym
- OSA
- Status last verified
- Apr 2012
- First submitted
- 5 Apr 2012
- Last updated
- 9 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Bariatric Surgery on Patients With Obstructive Sleep Apnea (OSA)
- ClinicalTrials.gov ID
- NCT01573676
- Acronym / sponsor ID
- OSA / 0048-11-HYMC
- Conditions
- Overweight, Obstructive Sleep Apnea
- Keywords
- bariatric surgery, sleep apnea, overweight
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- May 2012
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 9 Apr 2012 (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.
Obesity is a very important risk-factor in obstructive sleep apnea (OSA) and other sleep breathing disorders in patients with extreme BMI.
Candidates for bariatric surgery have a high OSA prevalence, ranging from 60-83%. The characteristics of patients with sleep apnea that were evaluated for bariatric surgery and had a full overnight polysomnography (PSG) screening for OSA were described and it was found that a very high prevalence (77.2%) for OSA in all subjects evaluated, regardless of pre-operative risk for OSA. A post-bariatric surgery PSG was not a part of this study.
The investigators would like to demonstrate the impact of bariatric surgery on OSA as a function of time.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bariatric surgery patients | – | –Candidates for bariatric surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- both males and females
Key inclusion criteria (1 listed)
- All candidates for bariatric surgery over 18 yrs of age
Key exclusion criteria (5 listed)
- Patients that underwent any OSA surgery in the past
- Patient had any bariatric surgery in the past
- Patients with COPD
- Patients with CHD
- Patients who have / had cancer that received chemotherapy or radiotherapy
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
Improvement in RDI after bariatric surgery
Time frame: Six months
Improvement will measured by polysonography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight and Obstructive Sleep Apnea, run by Hillel Yaffe Medical Center.
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 5 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 9 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Improvement in RDI after bariatric surgery (time frame: Six months). 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 9 Apr 2012.