Obstructive Sleep ApneaNCT00486746
Lifestyle Intervention Treatment for Patients With Mild Obstructive Sleep Apnea
A study testing Lifestyle intervention (physical activity and dietary counseling) and General information on healthy lifestyle habits in people with Obstructive Sleep Apnea, run by Kuopio University Hospital at 1 site in Finland.
Trial summary
The main objective of the study is to determine whether a supervised lifestyle intervention including individualized dietary counseling could be a curative treatment for patients with mild OSA. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Lifestyle intervention (physical activity and dietary counseling) and General information on healthy lifestyle habits
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteFinland
- Study dates
- Oct 2004to 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
- Age 18-65 years
- Apnea-hypopnea index 5-15
- BMI 28-40
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The main objective of the study is to determine whether a supervised lifestyle intervention including individualized dietary counseling could be a curative treatment for patients with mild OSA.
Read the detailed description
Obstructive sleep apnea (OSA) is one of the most common sleep disturbances, and it has been estimated that one out of five adults has at least some degree of sleep related breathing disturbances. Obstructive sleep apnea affects mostly the middle-aged work force, and causes a negative impact on public health by increasing both morbidity and mortality. Obesity is related to many diseases including diabetes, cardiovascular diseases, and metabolic syndrome,and obesity is also considered as the most important risk factor for OSA.Considering the prevalence of mild OSA, and the beneficial effects of even a slight weight loss on both the severity of OSA and the likelihood of developing OSA, lifestyle intervention including weight reduction represents a viable option for the treatment of patients with mild OSA.However, although included in the clinical guidelines, there is a definite lack of well executed studies on the effect of weight reduction upon OSA. Accordingly, we are conducting a randomized study on the effects of lifestyle intervention in the most prevalent subgroup of OSA patients, overweight patients with mild OSA. The study is an on-going prospective, randomized, parallel group trial. The main objective of the study is to determine whether a supervised lifestyle intervention including individualized dietary counseling could be a curative treatment for patients with mild OSA.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Lifestyle intervention (physical activity and dietary counseling), General information on healthy lifestyle habits
- Keywords
- sleep apnea, lifestyle intervention, cardiovascular
- Medical subject headings
- 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.
Lifestyle intervention (physical activity and dietary counseling)Behavioural
One-year intervention
General information on healthy lifestyle habitsBehavioural
A single session
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle intervention | Experimental | Not described Receives: Behavioral: Lifestyle intervention (physical activity and dietary counseling) |
| General health counseling | Active comparator | Not described Receives: Behavioral: General information on healthy lifestyle habits |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate, if weight reduction and lifestyle intervention improve the symptoms of mild obstructive sleep apnoea
Measured: 3 months
To evaluate, if these favourable changes remain in follow-up.
Measured: 1, 2 and 5 years
Secondary outcomes (3)
To evaluate, whether the treatment of mild OSA prevents the development of diseases in general associated with sleep apnoea
Measured: 5 years
To evaluate, whether the mild OSA has detrimental effects on cardiovascular functions and glucose-, insulin- and lipid metabolisms, regulation of autonomous nervous system, endothelial function, baroreflex sensitivity
Measured: baseline, 3 months, 1, 2 and 5 years
To evaluate, if improvement of mild OSA has beneficial influence on quality of life, cardiovascular functions and glucose-, insulin- and lipid metabolisms, regulation of autonomous nervous system, endothelial function, and anatomy of the pharynx
Measured: 1,2,5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2007 (estimated)
- Study startOct 2004
- Primary completionDec 2007
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Eastern Finland, Finnish Institute for Health and Welfare
- Responsible party
- Principal investigator, Juha Seppa, Kuopio University Hospital
- Investigators
- Henri Tuomilehto, PhD, Study director, Kuopion University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00486746
- Sponsor's protocol ID
- KUH5551811
- Status last verified
- Feb 2020
- First submitted
- 14 Jun 2007
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Tuomilehto H, Seppa J, Uusitupa M, Tuomilehto J, Gylling H; Kuopio Sleep Apnea Group. Weight reduction and increased physical activity to prevent the progression of obstructive sleep apnea: A 4-year observational postintervention follow-up of a randomized clinical trial. [corrected]. JAMA Intern Med. 2013 May 27;173(10):929-30. doi: 10.1001/jamainternmed.2013.389. No abstract available.
PubMed 23589169Lehto SM, Sahlman J, Soini EJ, Gylling H, Vanninen E, Seppa J, Viinamaki H, Tuomilehto H. The association between anxiety and the degree of illness in mild obstructive sleep apnoea. Clin Respir J. 2013 Apr;7(2):197-203. doi: 10.1111/j.1752-699X.2012.00304.x.
PubMed 22686135Sahlman J, Seppa J, Herder C, Peltonen M, Peuhkurinen K, Gylling H, Vanninen E, Tukiainen H, Punnonen K, Partinen M, Uusitupa M, Tuomilehto H. Effect of weight loss on inflammation in patients with mild obstructive sleep apnea. Nutr Metab Cardiovasc Dis. 2012 Jul;22(7):583-90. doi: 10.1016/j.numecd.2010.10.007. Epub 2010 Dec 28.
PubMed 21193295Tuomilehto H, Gylling H, Peltonen M, Martikainen T, Sahlman J, Kokkarinen J, Randell J, Tukiainen H, Vanninen E, Partinen M, Tuomilehto J, Uusitupa M, Seppa J; Kuopio Sleep Apnea Group. Sustained improvement in mild obstructive sleep apnea after a diet- and physical activity-based lifestyle intervention: postinterventional follow-up. Am J Clin Nutr. 2010 Oct;92(4):688-96. doi: 10.3945/ajcn.2010.29485. Epub 2010 Aug 11.
PubMed 20702607Kemppainen T, Ruoppi P, Seppa J, Sahlman J, Peltonen M, Tukiainen H, Gylling H, Vanninen E, Tuomilehto H. Effect of weight reduction on rhinometric measurements in overweight patients with obstructive sleep apnea. Am J Rhinol. 2008 Jul-Aug;22(4):410-5. doi: 10.2500/ajr.2008.22.3203.
PubMed 18702908
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
- Lifestyle Intervention Treatment for Patients With Mild Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT00486746
- Acronym / sponsor ID
- KUH5551811
- Conditions
- Obstructive Sleep Apnea
- Keywords
- sleep apnea, lifestyle intervention, cardiovascular
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- University of Eastern Finland, Finnish Institute for Health and Welfare
- Study start
- Oct 2004 (actual)
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2021 (estimated)
- First posted
- 15 Jun 2007 (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.
The main objective of the study is to determine whether a supervised lifestyle intervention including individualized dietary counseling could be a curative treatment for patients with mild OSA.
Detailed description
Obstructive sleep apnea (OSA) is one of the most common sleep disturbances, and it has been estimated that one out of five adults has at least some degree of sleep related breathing disturbances. Obstructive sleep apnea affects mostly the middle-aged work force, and causes a negative impact on public health by increasing both morbidity and mortality. Obesity is related to many diseases including diabetes, cardiovascular diseases, and metabolic syndrome,and obesity is also considered as the most important risk factor for OSA.Considering the prevalence of mild OSA, and the beneficial effects of even a slight weight loss on both the severity of OSA and the likelihood of developing OSA, lifestyle intervention including weight reduction represents a viable option for the treatment of patients with mild OSA.However, although included in the clinical guidelines, there is a definite lack of well executed studies on the effect of weight reduction upon OSA. Accordingly, we are conducting a randomized study on the effects of lifestyle intervention in the most prevalent subgroup of OSA patients, overweight patients with mild OSA. The study is an on-going prospective, randomized, parallel group trial. The main objective of the study is to determine whether a supervised lifestyle intervention including individualized dietary counseling could be a curative treatment for patients with mild OSA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle intervention | Experimental | Behavioral: Lifestyle intervention (physical activity and dietary counseling) |
| General health counseling | Active comparator | Behavioral: General information on healthy lifestyle habits |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-65 years
- Apnea-hypopnea index 5-15
- BMI 28-40
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Lifestyle intervention (physical activity and dietary counseling)One-year intervention | Behavioural | Lifestyle intervention |
| General information on healthy lifestyle habitsA single session | Behavioural | General health counseling |
Primary outcome
To evaluate, if weight reduction and lifestyle intervention improve the symptoms of mild obstructive sleep apnoea
Time frame: 3 months
To evaluate, if these favourable changes remain in follow-up.
Time frame: 1, 2 and 5 years
3 secondary outcomes
To evaluate, whether the treatment of mild OSA prevents the development of diseases in general associated with sleep apnoea
Time frame: 5 years
To evaluate, whether the mild OSA has detrimental effects on cardiovascular functions and glucose-, insulin- and lipid metabolisms, regulation of autonomous nervous system, endothelial function, baroreflex sensitivity
Time frame: baseline, 3 months, 1, 2 and 5 years
To evaluate, if improvement of mild OSA has beneficial influence on quality of life, cardiovascular functions and glucose-, insulin- and lipid metabolisms, regulation of autonomous nervous system, endothelial function, and anatomy of the pharynx
Time frame: 1,2,5 years
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 23589169Tuomilehto H, Seppa J, Uusitupa M, Tuomilehto J, Gylling H; Kuopio Sleep Apnea Group. Weight reduction and increased physical activity to prevent the progression of obstructive sleep apnea: A 4-year observational postintervention follow-up of a randomized clinical trial. [corrected]. JAMA Intern Med. 2013 May 27;173(10):929-30. doi: 10.1001/jamainternmed.2013.389. No abstract available.
- Derived from this study: PubMed 22686135Lehto SM, Sahlman J, Soini EJ, Gylling H, Vanninen E, Seppa J, Viinamaki H, Tuomilehto H. The association between anxiety and the degree of illness in mild obstructive sleep apnoea. Clin Respir J. 2013 Apr;7(2):197-203. doi: 10.1111/j.1752-699X.2012.00304.x.
- Derived from this study: PubMed 21193295Sahlman J, Seppa J, Herder C, Peltonen M, Peuhkurinen K, Gylling H, Vanninen E, Tukiainen H, Punnonen K, Partinen M, Uusitupa M, Tuomilehto H. Effect of weight loss on inflammation in patients with mild obstructive sleep apnea. Nutr Metab Cardiovasc Dis. 2012 Jul;22(7):583-90. doi: 10.1016/j.numecd.2010.10.007. Epub 2010 Dec 28.
- Derived from this study: PubMed 20702607Tuomilehto H, Gylling H, Peltonen M, Martikainen T, Sahlman J, Kokkarinen J, Randell J, Tukiainen H, Vanninen E, Partinen M, Tuomilehto J, Uusitupa M, Seppa J; Kuopio Sleep Apnea Group. Sustained improvement in mild obstructive sleep apnea after a diet- and physical activity-based lifestyle intervention: postinterventional follow-up. Am J Clin Nutr. 2010 Oct;92(4):688-96. doi: 10.3945/ajcn.2010.29485. Epub 2010 Aug 11.
- Derived from this study: PubMed 18702908Kemppainen T, Ruoppi P, Seppa J, Sahlman J, Peltonen M, Tukiainen H, Gylling H, Vanninen E, Tuomilehto H. Effect of weight reduction on rhinometric measurements in overweight patients with obstructive sleep apnea. Am J Rhinol. 2008 Jul-Aug;22(4):410-5. doi: 10.2500/ajr.2008.22.3203.
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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, PhD study director
Kuopion University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle intervention (physical activity and dietary counseling) and General information on healthy lifestyle habits in people with Obstructive Sleep Apnea, run by Kuopio University Hospital at 1 site 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 3 inclusion and 0 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 1 site 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?
To evaluate, if weight reduction and lifestyle intervention improve the symptoms of mild obstructive sleep apnoea (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT00486746, which also lists 5 linked publications.
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.