Sleep Apnea SyndromeNCT01354756
Validation of Apnea LinkTM for Sleep Apnea Syndrome Screening in a Bariatric Population
An observational study of Sleep Apnea Syndrome, run by Centre Hospitalier Universitaire Saint Pierre.
Trial summary
Sleep apnea syndrome (OSA) frequently occurs in obese population undergoing bariatric surgery. There is a need for alternative screening tools for sleep apnea detection in the pre-operative period. The investigators would like to compare ApneaLink and complete polysomnography in this population. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sleep Apnea Syndrome
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- Oct 2010to May 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: obese patients, > 18y old, in whom a bariatric surgery is planified and who have to undergo a polysomnography for OSA screening
Who may be able to join
- obese patients
- > 18 years old
- in whom a bariatric surgery is planified and who have to undergo a polysomnography for OSA screening
Who cannot join
- pulmonary, neurologic, neuromuscular disease
- < 18 years old
About this study
Official title: Validation of Apnea LinkTM (ResMed Corporation, Poway, California) for Sleep Apnea Syndrome Screening in a Bariatric Population
Sleep apnea syndrome (OSA) frequently occurs in obese population undergoing bariatric surgery. There is a need for alternative screening tools for sleep apnea detection in the pre-operative period. The investigators would like to compare ApneaLink and complete polysomnography in this population.
Read the detailed description
OSA can occur in up to 78% of patients undergoing bariatric surgery(1). Moderate to severe case will benefit from CPAP therapy, that can help avoiding post-operative complications(2).
In this population, the investigators propose complete attended in-hospital polysomnography (PSG)in patients with a clinical high probability of OSA.
According to obesity epidemics (3), waiting list for PSG in sleep labs is every day longer.
The investigators want to assess sensitivity and specificity of a new portable screening tool, ApneaLink, to detect OSA in a bariatric population.
Design:
monocentric and prospective study
Methods:
Patients:
- OSA suspicion based on :
- symptoms and signs (snoring, apneas , neck circumference >38 (women) or 43cm (men))
- BMI > 50
- BMI > 40, > 40 y
- BMI > 35, men, hypertension
- increased serum Bicarbonate
- Polyglobulia
Measurements
- Polysomnography in sleep lab with concommitant recording performed with Apnea LinkTM (nasal flow and oxymétry recording).
- between 2 weeks : recording performed with Apnea LinkTM (nasal flow and oxymétry recording)at home.
- Conditions
- Sleep Apnea Syndrome
- Keywords
- sleep apnea, polysomnography, obesity, bariatric surgery
- Medical subject headings
- Sleep Apnea Syndromes, Obesity
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 population | obese patients in whom a bariatric surgery is planified |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with correct diagnosis of OSA with ApneaLink. Therefore, we will compare apnea-hypopnea index measured with ApneaLink with apnea-hypopnea index measured during polysomnography.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2011 (estimated)
- Study startOct 2010
- Primary completionMay 2011
- Study completionMay 2011
Why it stopped: device was stolen
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea SyndromeStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Bruyneel, Centre Hospitalier Universitaire Saint Pierre
- Investigators
- Marie Bruyneel, MD, Principal investigator, CHU St Pierre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01354756
- Sponsor's protocol ID
- AK/10-09-3921/52
- Status last verified
- Mar 2015
- First submitted
- 6 May 2011
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Apnea LinkTM (ResMed Corporation, Poway, California) for Sleep Apnea Syndrome Screening in a Bariatric Population
- ClinicalTrials.gov ID
- NCT01354756
- Acronym / sponsor ID
- AK/10-09-3921/52
- Conditions
- Sleep Apnea Syndrome
- Keywords
- sleep apnea, polysomnography, obesity, bariatric surgery
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: device was stolen
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 17 May 2011 (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.
Sleep apnea syndrome (OSA) frequently occurs in obese population undergoing bariatric surgery. There is a need for alternative screening tools for sleep apnea detection in the pre-operative period. The investigators would like to compare ApneaLink and complete polysomnography in this population.
Detailed description
OSA can occur in up to 78% of patients undergoing bariatric surgery(1). Moderate to severe case will benefit from CPAP therapy, that can help avoiding post-operative complications(2).
In this population, the investigators propose complete attended in-hospital polysomnography (PSG)in patients with a clinical high probability of OSA.
According to obesity epidemics (3), waiting list for PSG in sleep labs is every day longer.
The investigators want to assess sensitivity and specificity of a new portable screening tool, ApneaLink, to detect OSA in a bariatric population.
Design:
monocentric and prospective study
Methods:
Patients:
- OSA suspicion based on :
- symptoms and signs (snoring, apneas , neck circumference >38 (women) or 43cm (men))
- BMI > 50
- BMI > 40, > 40 y
- BMI > 35, men, hypertension
- increased serum Bicarbonate
- Polyglobulia
Measurements
- Polysomnography in sleep lab with concommitant recording performed with Apnea LinkTM (nasal flow and oxymétry recording).
- between 2 weeks : recording performed with Apnea LinkTM (nasal flow and oxymétry recording)at home.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bariatric population | – | –obese patients in whom a bariatric surgery is planified |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- obese patients, > 18y old, in whom a bariatric surgery is planified and who have to undergo a polysomnography for OSA screening
Key inclusion criteria (3 listed)
- obese patients
- > 18 years old
- in whom a bariatric surgery is planified and who have to undergo a polysomnography for OSA screening
Key exclusion criteria (2 listed)
- pulmonary, neurologic, neuromuscular disease
- < 18 years old
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
Number of patients with correct diagnosis of OSA with ApneaLink. Therefore, we will compare apnea-hypopnea index measured with ApneaLink with apnea-hypopnea index measured during polysomnography.
Time frame: 2 weeks
Results and safety
The study was stopped early (reason given: device was stolen). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2015.
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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.
Marie Bruyneel, MD principal investigator
CHU St Pierre
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea Syndrome, run by Centre Hospitalier Universitaire Saint Pierre.
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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 10 Mar 2015. 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?
The study was stopped early (reason given: device was stolen). 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?
Number of patients with correct diagnosis of OSA with ApneaLink. Therefore, we will compare apnea-hypopnea index measured with ApneaLink with apnea-hypopnea index measured during polysomnography. (time frame: 2 weeks). 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 10 Mar 2015.