Obstructive Sleep Apnoea (OSA)NCT02012868
Effect of Bariatric Surgery on Obstructive Sleep Apnea in a Danish Cohort
An observational study of Obstructive Sleep Apnoea (OSA), run by University of Southern Denmark at 1 site in Denmark.
Trial summary
Studies have shown high prevalence (60-94%) of obstructive sleep apnoea (OSA) among patients undergoing bariatric surgery. Fifteen studies are published investigating the effect of bariatric surgery on OSA. All of them conclude a highly positive effect on OSA by bariatric surgery and weight loss. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnoea (OSA)
- What is being tested?
- bariatric surgery
- Type of treatment
- Surgery or procedure
- How many people
- 56 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2012to Jun 2014
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients attending bariatric surgery
Who may be able to join
- BMI > 35
- attending bariatric surgery
Who cannot join
- retrognathia
- micrognathia,
- acromegaly
- downs syndrome
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of endocrinology, Southern west hospital
Esbjerg, 6700
About this study
Studies have shown high prevalence (60-94%) of obstructive sleep apnoea (OSA) among patients undergoing bariatric surgery.
Fifteen studies are published investigating the effect of bariatric surgery on OSA. All of them conclude a highly positive effect on OSA by bariatric surgery and weight loss. However these studies are biased by a huge number of drop outs. The drop out rate in the studies are around 60 percent.
The Investigators state that the prevalence of OSA among patients undergoing bariatric surgery in Denmark is high. The Investigators state that the effect of bariatric surgery is significant on severity of OSA. The Investigators state that we can perform a study without a huge number of dropouts.
Read the detailed description
Obstructive sleep apnea (OSA) is a clinical syndrome characterized by occlusion of upper airways during sleep. The occlusions results in shortly hypoxia, which awakes the patient. When the patient awakes, activity in the pharyngeal muscles results in opening of the upper airway again.
OSA is associated with overweight. Studies have shown high prevalence (60-94%) of obstructive sleep apnea (OSA) among patients undergoing gastric bypass (bariatric) surgery.
Fifteen studies have investigated the effect of bariatric surgery on OSA. All of them conclude a highly positive effect on OSA by bariatric surgery and the following weight loss. However, a huge number of dropouts biases these studies. The dropout rate in the studies are around 60 percent. No studies are from northern Europe.
The Investigators want to perform a study investigating the prevalence of OSA among over weighted patients undergoing bariatric surgery in Denmark.
The Investigators state that the prevalence of OSA among patients undergoing bariatric surgery in Denmark is high. The investigators state that the effect of bariatric surgery is significant on severity of OSA. The Investigators state that they can perform a study without a huge number of dropouts.
The investigators investigate patients by making sleep monitoring by embletta. During one night of sleep with this apparatus, the investigators will get information on number of wake-ups during sleep, the apnea-hypopnea index and saturation during sleep. All of this gives the investigators information whether the patient have OSA or not.
Patients will undergo sleep monitoring prior to surgery. The time interval from monitoring to day of surgery varies from 1 month to one day. the investigators repeat the sleep monitoring one year after date of surgery. Differences in primary endpoint and secondary endpoints is calculated.
Today all of the subjects have undergone surgery. From November 1.2013 the investigators invites all patients to sleep monitoring once again. The investigators were hot able to register this trial before this date because of the political situation in the US. This site was closed. The Investigators hope that the investigators still are able to register the study.
- Conditions
- Obstructive Sleep Apnoea (OSA)
- Being tested
- bariatric surgery
- Keywords
- obstructive sleep apnoea, weight loss, bariatric surgery
- Medical subject headings
- Sleep Apnea, Obstructive, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bariatric surgeryProcedure or surgery
Also called gastric bypass
| Study group | Role | What they receive |
|---|---|---|
| bariatric surgery, obstructive sleep apnoea | bariatric surgery Receives: Procedure: bariatric surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
AHI
Obstructive sleep apnoea is defined by the apnoea/hypopnoea index (AHI). This can be accessed by embletta monitoring during sleep.
Measured: Change from baseline in AHI at one year
Secondary outcomes (3)
weight
No need.
Measured: Change from baseline in weight at one year
Circumference of neck
Circumference of the neck measured in inches.
Measured: Change from baseline in Circumference at neck at one year
mean saturation during sleep
saturation during sleep is measured by a pulsoxymetry.
Measured: Change from baseline in mean saturation during sleep at one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2013 (estimated)
- Study startMar 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnoea (OSA)Studies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeppe Gram, University of Southern Denmark
- Investigators
- Philip Lage-Hansen, Doctor, Principal investigator, Department of endocrinology, Esbjerg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02012868
- Sponsor's protocol ID
- S-20120004jln
- Status last verified
- Mar 2020
- First submitted
- 26 Nov 2013
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bariatric Surgery on Obstructive Sleep Apnea in a Danish Cohort
- ClinicalTrials.gov ID
- NCT02012868
- Acronym / sponsor ID
- S-20120004jln
- Conditions
- Obstructive Sleep Apnoea (OSA)
- Keywords
- obstructive sleep apnoea, weight loss, bariatric surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- Mar 2012 (actual)
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 16 Dec 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.
Studies have shown high prevalence (60-94%) of obstructive sleep apnoea (OSA) among patients undergoing bariatric surgery.
Fifteen studies are published investigating the effect of bariatric surgery on OSA. All of them conclude a highly positive effect on OSA by bariatric surgery and weight loss. However these studies are biased by a huge number of drop outs. The drop out rate in the studies are around 60 percent.
The Investigators state that the prevalence of OSA among patients undergoing bariatric surgery in Denmark is high. The Investigators state that the effect of bariatric surgery is significant on severity of OSA. The Investigators state that we can perform a study without a huge number of dropouts.
Detailed description
Obstructive sleep apnea (OSA) is a clinical syndrome characterized by occlusion of upper airways during sleep. The occlusions results in shortly hypoxia, which awakes the patient. When the patient awakes, activity in the pharyngeal muscles results in opening of the upper airway again.
OSA is associated with overweight. Studies have shown high prevalence (60-94%) of obstructive sleep apnea (OSA) among patients undergoing gastric bypass (bariatric) surgery.
Fifteen studies have investigated the effect of bariatric surgery on OSA. All of them conclude a highly positive effect on OSA by bariatric surgery and the following weight loss. However, a huge number of dropouts biases these studies. The dropout rate in the studies are around 60 percent. No studies are from northern Europe.
The Investigators want to perform a study investigating the prevalence of OSA among over weighted patients undergoing bariatric surgery in Denmark.
The Investigators state that the prevalence of OSA among patients undergoing bariatric surgery in Denmark is high. The investigators state that the effect of bariatric surgery is significant on severity of OSA. The Investigators state that they can perform a study without a huge number of dropouts.
The investigators investigate patients by making sleep monitoring by embletta. During one night of sleep with this apparatus, the investigators will get information on number of wake-ups during sleep, the apnea-hypopnea index and saturation during sleep. All of this gives the investigators information whether the patient have OSA or not.
Patients will undergo sleep monitoring prior to surgery. The time interval from monitoring to day of surgery varies from 1 month to one day. the investigators repeat the sleep monitoring one year after date of surgery. Differences in primary endpoint and secondary endpoints is calculated.
Today all of the subjects have undergone surgery. From November 1.2013 the investigators invites all patients to sleep monitoring once again. The investigators were hot able to register this trial before this date because of the political situation in the US. This site was closed. The Investigators hope that the investigators still are able to register the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bariatric surgery, obstructive sleep apnoea | – | Procedure: bariatric surgerybariatric surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients attending bariatric surgery
Key inclusion criteria (2 listed)
- BMI > 35
- attending bariatric surgery
Key exclusion criteria (4 listed)
- retrognathia
- micrognathia,
- acromegaly
- downs syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bariatric surgeryAlso: gastric bypass | Procedure or surgery | bariatric surgery, obstructive sleep apnoea |
Primary outcome
AHI
Time frame: Change from baseline in AHI at one year
Obstructive sleep apnoea is defined by the apnoea/hypopnoea index (AHI). This can be accessed by embletta monitoring during sleep.
3 secondary outcomes
weight
Time frame: Change from baseline in weight at one year
Circumference of neck
Time frame: Change from baseline in Circumference at neck at one year
mean saturation during sleep
Time frame: Change from baseline in mean saturation during sleep at one year
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 25 Mar 2020.
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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.
Philip Lage-Hansen, Doctor principal investigator
Department of endocrinology, Esbjerg
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 Apnoea (OSA), run by University of Southern Denmark at 1 site in Denmark.
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 25 Mar 2020. 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 Denmark. 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?
AHI (time frame: Change from baseline in AHI at one year). 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 25 Mar 2020; AzTrials last refreshed its copy on 7 Nov 2026.