Obstructive Sleep ApneaNCT01080404
A Study of Surgical Weight Loss to Treat Obstructive Sleep Apnea
A study testing Bariatric surgery and Continuous positive airway pressure in people with Obstructive Sleep Apnea and Obesity, run by Kuopio University Hospital at 9 sites in Finland.
Trial summary
Obesity is an increasing problem worldwide. Over 20% of people in western societies are obese (BMI >30kg/m2) and 1-2 % are morbidly obese (BMI >40 kg/m2). According to the recent study 6.6% of Finns are severely obese (BMI > 35kg/m2) and 2.0% are morbidly obese (BMI>40kg/m2). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnea, Obesity
- What is being tested?
- Bariatric surgery and Continuous positive airway pressure
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- 9 sitesFinland
- Study dates
- May 2010to Dec 2021
- Phase
- Interventional
- 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
Who may be able to join
- For the overall study:
- Age 18-65 years
- BMI 35 and over with comorbidity (such as sleep apnea)
- BMI 40 and over without any comorbidities
- Obtained written consent
- Additionally for the randomised substudy:
- BMI 35-45
- AHI 5-30
Who cannot join
- On-going active treatment of OSA of any kind (during the last 1 month)
- Pregnancy
- Alcoholism
- Eating disorders or severe depression
- Other severe diseases contra-indicating bariatric surgery
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Finland9 sites
Helsinki University hospital
Helsinki, 00029
National Institute for Health and Welfare
Helsinki, 00271
Helsinki Sleep Center
Helsinki, 00420
Eastern Finland Laboratory Centre
Kuopio, 70211
Kuopio University hospital
Kuopio, 70211
Päijät-Häme Central hospital
Lahti, 15850
Oulu University hospital
Oulu, 90029
Turku University hospital
Turku, 20521
Vaasa Central hospital
Vaasa, 65100
About this study
Official title: Obesity, Metabolism and Obstructive Sleep Apnea: Prevalence and the Effect of Bariatric Surgery
Obesity is an increasing problem worldwide. Over 20% of people in western societies are obese (BMI >30kg/m2) and 1-2 % are morbidly obese (BMI >40 kg/m2). According to the recent study 6.6% of Finns are severely obese (BMI > 35kg/m2) and 2.0% are morbidly obese (BMI>40kg/m2). Because conventional treatments often fail to induce sustained weight loss obesity surgery has increased rapidly in many countries. Currently, > 300000 procedures are performed in the US each year. Thus in many European countries, including Finland, the need for obesity surgery is rapidly increasing.
The most important risk factor also for obstructive sleep apnea (OSA) is obesity, and thus effective treatment of obesity is the first-line treatment of OSA. However, Reliable information of the prevalence of OSA in morbidly obese patients is still lacking. The current knowledge is based on small studies, which have demonstrated that the prevalence of OSA may be higher than believed, even 70-80% in morbidly obese patients. There is a definite need for large, well-designed, prospective clinical studies to evaluate the effects of weight reduction in OSA and other co-morbidities related to obesity. Ever increasing research data showing a strong link between obesity and OSA and their co-existence as a major risk factor in the development of cardiovascular diseases should provoke concepts to search better clinical guidelines of diagnostics and treatments in a risk group, such as morbidly obese patients.
Read the detailed description
Sleep disturbances have become a public health concern in the modern society, affecting millions of people. Obstructive sleep apnea (OSA) is one of the commonest sleep disturbances. Obstructive sleep apnea affects mostly middle-aged work force, causing a negative impact on public health since it increases both mortality and morbidity. In Finland, there are approximately 150,000 OSA patients, of whom 15,000 patients have a severe, 50,000 a moderate and 85,000 a mild form of the disease. The number of the patients is assumed to be strongly underestimated and it has been estimated that one out of five adults has at least mild OSA. OSA is tightly linked with metabolic abnormalities that contribute to an increased morbidity and mortality through cardiovascular disease. In addition, accidents by daytime sleepiness deteriorate person's quality of life and working capacity.
The most important risk factor for OSA is obesity, and thus effective treatment of obesity is first-line treatment of OSA. In a recent study it was observed that lifestyle intervention with an early weight reduction can be a curative treatment is mild OSA. However, regardless of these promising results weight reduction as a treatment of OSA is still underestimated. Particularly alarming is the exploding prevalence of morbid obesity, and that estimations have predicted this group of patients to increase most rapidly. Unfortunately, conventional lifestyle and weight reduction interventions have proven to be ineffective in long-term follow-up in these patients. In contrast, the permanent weight reduction achieved by bariatric surgery has been found to have favourable effects on diabetes, hyperlipidemia, hypertension, and also on OSA.
The treatment of OSA is demanding for both patients and physicians. There are no simple treatment modalities. Thus, there exists a definite need to improve the existing treatment modalities and to search new ones. The golden standard for treating patients with OSA is nasal continuous airway pressure (CPAP). It has been found to effective, but somewhat poor adherence (40-50%) to the treatment is certainly a major limitation. Moreover, there is little evidence about the possible beneficial metabolic effects of CPAP. Considering the rapid increase of obesity and the unsatisfactory adherence to CPAP treatment, bariatric surgery offers an interesting and viable option alongside with the conventional treatment modalities of OSA. Reliable information of the prevalence of OSA in morbidly obese patients is still lacking. The current knowledge is based on small studies, which have demonstrated that the prevalence of OSA could be higher than believed, even 70-80% in morbidly obese patients. There is a definite need for large, well-designed, prospective clinical studies on the effects of weight reduction in OSA and other co-morbidities related to obesity. Ever increasing research data showing a strong link between obesity and OSA and OSA as a major risk factor in the development of cardiovascular diseases should provoke concepts to improve better clinical guidelines of diagnostics and treatments in a risk group, such as obese patients.
- Conditions
- Obstructive Sleep Apnea, Obesity
- Being tested
- Bariatric surgery, Continuous positive airway pressure
- Keywords
- Obstructive sleep apnea, Obesity, Metabolism, Bariatric surgery, CPAP
- Medical subject headings
- Sleep Apnea, Obstructive, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgeryProcedure or surgery
A standardized laparoscopic gastric bypass using Roux-en-Y technique
Continuous positive airway pressureDevice
The patients are given standardized CPAP treatment according to current clinical guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Bariatric surgery (overall study) | Experimental | A prospective follow-up study is to estimate the prevalence of OSA and associated metabolic abnormalities in Finnish morbidly obese subjects and to evaluate the effects of bariatric surgery on OSA and associated metabolic abnormalities. The study is conducted in seven hospitals in Finland and 300 patients are planned to be recruited in the study. Receives: Procedure: Bariatric surgery |
| Bariatric surgery (randomised substudy) | Experimental | As a substudy of a larger trial, a randomized study on the effects of bariatric surgery compared to CPAP treatment will be performed in obese (BMI 35-45) patients with OSA. The included 100 (15/center) patients are randomised to two groups: surgical intervention group (50) and CPAP group (50). Patients in the surgical intervention group undergo standardised surgical treatment (laparoscopic gastric bypass), including general health information, such as avoidance of smoking, alcohol drinking, and importance of healthy nutrition and regular exercise. The CPAP group will be assigned to CPAP treatment and they also receive the general health information. Receives: Procedure: Bariatric surgery |
| CPAP (randomised substudy) | Active comparator | As a substudy of a larger trial, a randomized study on the effects of bariatric surgery compared to CPAP treatment will be performed in obese (BMI 35-45) patients with OSA. The included 100 patients are randomised to two groups: surgical intervention group (50) and CPAP group (50). Patients in the surgical intervention group undergo standardised surgical treatment (laparoscopic gastric bypass), including general health information, such as avoidance of smoking, alcohol drinking, and importance of healthy nutrition and regular exercise. The CPAP group will be assigned to CPAP treatment and they also receive the general health information. Receives: Device: Continuous positive airway pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of bariatric surgery as a treatment of OSA
To evaluate the effect of bariatric surgery as a treatment of OSA measured by objective (cardio-respiratory recording) and subjective parameters (questionnaires).
Measured: 1- and 5-year follow-up
Secondary outcomes (7)
The prevalence of OSA in morbidly obese patients undergoing bariatric surgery
To detect the prevalence of OSA in morbidly obese patients undergoing bariatric surgery in Finland.
Measured: At the baseline
The effect of bariatric surgery compared with CPAP treatment as a treatment of OSA
To evaluate the effect of bariatric surgery compared with CPAP treatment as a treatment of OSA measured by objective (cardio-respiratory recording) and subjective (questionnaires) parameters.
Measured: 6-month follow-up
The effect of surgically induced weight loss on metabolism.
To study the effect of surgically induced weight loss on glucose tolerance, insulin resistance and lipid and energy metabolism.
Measured: 3-, 6-, 12-, 60-month follow-up
The effect of weight loss on low-grade inflammation and peripheral blood mononuclear cells (PBMCs) gene expression
To study the effect of weight loss on OSA, low-grade inflammation and peripheral blood mononuclear cells (PBMCs) gene expression
Measured: 3-, 6-, 12-, 60-month follow-up
The postoperative recovery after bariatric surgery
To evaluate the postoperative recovery after bariatric surgery
Measured: 3-, 6-, 12-, 60-month follow-up
The effect of CPAP treatment on metabolism in morbidly obese patients with OSA
To evaluate the effect of CPAP treatment on metabolism in obese patients with OSA
Measured: 3-, 6-month follow-up
The effect of CPAP treatment combined with bariatric surgery in obese patients with OSA.
To evaluate the effect of CPAP treatment combined with bariatric surgery in obese patients with OSA.
Measured: 1- and 5-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2010 (estimated)
- Study startMay 2010
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinki University Central Hospital, Turku University Hospital, Oulu University Hospital, Vaasa Central Hospital, Vaasa, Finland, Finnish Institute for Health and Welfare, Helsingin Uniklinikka, Kanta-Häme Central Hospital
- Responsible party
- Principal investigator, Juha Seppa, Kuopio University Hospital
- Investigators
- Henri Tuomilehto, MD, PhD, Study director, Kuopio University HospitalMikael Victorzon, MD, PhD, Principal investigator, Vaasa Central Hospital, Vaasa, FinlandJussi Pihlajamäki, MD, PhD, Principal investigator, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01080404
- Sponsor's protocol ID
- KUH5551821
- Status last verified
- Feb 2020
- First submitted
- 3 Mar 2010
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Peromaa-Haavisto P, Tuomilehto H, Kossi J, Virtanen J, Luostarinen M, Pihlajamaki J, Kakela P, Victorzon M. Obstructive sleep apnea: the effect of bariatric surgery after 12 months. A prospective multicenter trial. Sleep Med. 2017 Jul;35:85-90. doi: 10.1016/j.sleep.2016.12.017. Epub 2017 Jan 12.
PubMed 28549834
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity, Metabolism and Obstructive Sleep Apnea: Prevalence and the Effect of Bariatric Surgery
- ClinicalTrials.gov ID
- NCT01080404
- Acronym / sponsor ID
- KUH5551821
- Conditions
- Obstructive Sleep Apnea, Obesity
- Keywords
- Obstructive sleep apnea, Obesity, Metabolism, Bariatric surgery, CPAP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- Helsinki University Central Hospital, Turku University Hospital, Oulu University Hospital, Vaasa Central Hospital, Vaasa, Finland, Finnish Institute for Health and Welfare, Helsingin Uniklinikka, Kanta-Häme Central Hospital
- Study start
- May 2010 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 4 Mar 2010 (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 an increasing problem worldwide. Over 20% of people in western societies are obese (BMI >30kg/m2) and 1-2 % are morbidly obese (BMI >40 kg/m2). According to the recent study 6.6% of Finns are severely obese (BMI > 35kg/m2) and 2.0% are morbidly obese (BMI>40kg/m2). Because conventional treatments often fail to induce sustained weight loss obesity surgery has increased rapidly in many countries. Currently, > 300000 procedures are performed in the US each year. Thus in many European countries, including Finland, the need for obesity surgery is rapidly increasing.
The most important risk factor also for obstructive sleep apnea (OSA) is obesity, and thus effective treatment of obesity is the first-line treatment of OSA. However, Reliable information of the prevalence of OSA in morbidly obese patients is still lacking. The current knowledge is based on small studies, which have demonstrated that the prevalence of OSA may be higher than believed, even 70-80% in morbidly obese patients. There is a definite need for large, well-designed, prospective clinical studies to evaluate the effects of weight reduction in OSA and other co-morbidities related to obesity. Ever increasing research data showing a strong link between obesity and OSA and their co-existence as a major risk factor in the development of cardiovascular diseases should provoke concepts to search better clinical guidelines of diagnostics and treatments in a risk group, such as morbidly obese patients.
Detailed description
Sleep disturbances have become a public health concern in the modern society, affecting millions of people. Obstructive sleep apnea (OSA) is one of the commonest sleep disturbances. Obstructive sleep apnea affects mostly middle-aged work force, causing a negative impact on public health since it increases both mortality and morbidity. In Finland, there are approximately 150,000 OSA patients, of whom 15,000 patients have a severe, 50,000 a moderate and 85,000 a mild form of the disease. The number of the patients is assumed to be strongly underestimated and it has been estimated that one out of five adults has at least mild OSA. OSA is tightly linked with metabolic abnormalities that contribute to an increased morbidity and mortality through cardiovascular disease. In addition, accidents by daytime sleepiness deteriorate person's quality of life and working capacity.
The most important risk factor for OSA is obesity, and thus effective treatment of obesity is first-line treatment of OSA. In a recent study it was observed that lifestyle intervention with an early weight reduction can be a curative treatment is mild OSA. However, regardless of these promising results weight reduction as a treatment of OSA is still underestimated. Particularly alarming is the exploding prevalence of morbid obesity, and that estimations have predicted this group of patients to increase most rapidly. Unfortunately, conventional lifestyle and weight reduction interventions have proven to be ineffective in long-term follow-up in these patients. In contrast, the permanent weight reduction achieved by bariatric surgery has been found to have favourable effects on diabetes, hyperlipidemia, hypertension, and also on OSA.
The treatment of OSA is demanding for both patients and physicians. There are no simple treatment modalities. Thus, there exists a definite need to improve the existing treatment modalities and to search new ones. The golden standard for treating patients with OSA is nasal continuous airway pressure (CPAP). It has been found to effective, but somewhat poor adherence (40-50%) to the treatment is certainly a major limitation. Moreover, there is little evidence about the possible beneficial metabolic effects of CPAP. Considering the rapid increase of obesity and the unsatisfactory adherence to CPAP treatment, bariatric surgery offers an interesting and viable option alongside with the conventional treatment modalities of OSA. Reliable information of the prevalence of OSA in morbidly obese patients is still lacking. The current knowledge is based on small studies, which have demonstrated that the prevalence of OSA could be higher than believed, even 70-80% in morbidly obese patients. There is a definite need for large, well-designed, prospective clinical studies on the effects of weight reduction in OSA and other co-morbidities related to obesity. Ever increasing research data showing a strong link between obesity and OSA and OSA as a major risk factor in the development of cardiovascular diseases should provoke concepts to improve better clinical guidelines of diagnostics and treatments in a risk group, such as obese patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bariatric surgery (overall study) | Experimental | Procedure: Bariatric surgeryA prospective follow-up study is to estimate the prevalence of OSA and associated metabolic abnormalities in Finnish morbidly obese subjects and to evaluate the effects of bariatric surgery on OSA and associated metabolic abnormalities. The study is conducted in seven hospitals in Finland and 300 patients are planned to be recruited in the study. |
| Bariatric surgery (randomised substudy) | Experimental | Procedure: Bariatric surgeryAs a substudy of a larger trial, a randomized study on the effects of bariatric surgery compared to CPAP treatment will be performed in obese (BMI 35-45) patients with OSA. The included 100 (15/center) patients are randomised to two groups: surgical intervention group (50) and CPAP group (50). Patients in the surgical intervention group undergo standardised surgical treatment (laparoscopic gastric bypass), including general health information, such as avoidance of smoking, alcohol drinking, and importance of healthy nutrition and regular exercise. The CPAP group will be assigned to CPAP treatment and they also receive the general health information. |
| CPAP (randomised substudy) | Active comparator | Device: Continuous positive airway pressureAs a substudy of a larger trial, a randomized study on the effects of bariatric surgery compared to CPAP treatment will be performed in obese (BMI 35-45) patients with OSA. The included 100 patients are randomised to two groups: surgical intervention group (50) and CPAP group (50). Patients in the surgical intervention group undergo standardised surgical treatment (laparoscopic gastric bypass), including general health information, such as avoidance of smoking, alcohol drinking, and importance of healthy nutrition and regular exercise. The CPAP group will be assigned to CPAP treatment and they also receive the general health information. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18-65 years
- BMI 35 and over with comorbidity (such as sleep apnea)
- BMI 40 and over without any comorbidities
- Obtained written consent
- BMI 35-45
Key exclusion criteria (5 listed)
- On-going active treatment of OSA of any kind (during the last 1 month)
- Pregnancy
- Alcoholism
- Eating disorders or severe depression
- Other severe diseases contra-indicating bariatric surgery
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 surgeryA standardized laparoscopic gastric bypass using Roux-en-Y technique | Procedure or surgery | Bariatric surgery (overall study), Bariatric surgery (randomised substudy) |
| Continuous positive airway pressureThe patients are given standardized CPAP treatment according to current clinical guidelines. | Device | CPAP (randomised substudy) |
Primary outcome
The effect of bariatric surgery as a treatment of OSA
Time frame: 1- and 5-year follow-up
To evaluate the effect of bariatric surgery as a treatment of OSA measured by objective (cardio-respiratory recording) and subjective parameters (questionnaires).
7 secondary outcomes
The prevalence of OSA in morbidly obese patients undergoing bariatric surgery
Time frame: At the baseline
The effect of bariatric surgery compared with CPAP treatment as a treatment of OSA
Time frame: 6-month follow-up
The effect of surgically induced weight loss on metabolism.
Time frame: 3-, 6-, 12-, 60-month follow-up
The effect of weight loss on low-grade inflammation and peripheral blood mononuclear cells (PBMCs) gene expression
Time frame: 3-, 6-, 12-, 60-month follow-up
The postoperative recovery after bariatric surgery
Time frame: 3-, 6-, 12-, 60-month follow-up
The effect of CPAP treatment on metabolism in morbidly obese patients with OSA
Time frame: 3-, 6-month follow-up
The effect of CPAP treatment combined with bariatric surgery in obese patients with OSA.
Time frame: 1- and 5-year follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Derived from this study: PubMed 28549834Peromaa-Haavisto P, Tuomilehto H, Kossi J, Virtanen J, Luostarinen M, Pihlajamaki J, Kakela P, Victorzon M. Obstructive sleep apnea: the effect of bariatric surgery after 12 months. A prospective multicenter trial. Sleep Med. 2017 Jul;35:85-90. doi: 10.1016/j.sleep.2016.12.017. Epub 2017 Jan 12.
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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.
Henri Tuomilehto, MD, PhD study director
Kuopio University Hospital
Mikael Victorzon, MD, PhD principal investigator
Vaasa Central Hospital, Vaasa, Finland
Jussi Pihlajamäki, MD, PhD principal investigator
Kuopio University Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bariatric surgery and Continuous positive airway pressure in people with Obstructive Sleep Apnea and Obesity, run by Kuopio University Hospital at 9 sites in Finland.
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 8 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 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Finland. 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?
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?
The effect of bariatric surgery as a treatment of OSA (time frame: 1- and 5-year follow-up). 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 NCT01080404, which also lists 1 linked publication.
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 20 Feb 2020.