Obstructive Sleep Apnea SyndromeNCT01215617
The Effect of Aerobic Interval Training on Obstructive Sleep Apnea
A study testing Aerobic Interval training in people with Obstructive Sleep Apnea Syndrome, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The purpose of this study is to investigate if 3 months of interval training improves obstructive sleep apnea in obese patients diagnosed with moderate to severe obstructive sleep apnea. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome
- What is being tested?
- Aerobic Interval training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2010to Oct 2013
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI ≥ 30 kg/M2
- Apne - hypopnea index (AHI) > 10
- No significant comorbidities
- Abel to exercise
Who cannot join
- Inability to exercise due to musculoskeletal conditions
- Known ischemic cardiovascular disease
- Drug abuse
- Mental illnesses
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Aerobic Interval Training on Obstructive Sleep Apnea, Cardiovascular and Pulmonary Function in Obese Patients
The purpose of this study is to investigate if 3 months of interval training improves obstructive sleep apnea in obese patients diagnosed with moderate to severe obstructive sleep apnea. The working hypothesis is that 3 months of 3 weekly aerobic interval training sessions improve obstructive sleep apnea and sleep quality in obese patients.
Read the detailed description
Obstructive sleep apnea syndrome (OSAS) is characterized by repetitive obstruction and collapse of the upper airway resulting in successive episodes of cessation of or decreased respiratory airflow, causing oxygen desaturation, awakening, loud snoring and daytime sleepiness in patients. Sleep apnea is frequently associated with co-morbidity such as obesity, diabetes, hypertension, the metabolic syndrome and cardiovascular disease. Lack of exercise is associated with OSAS severity, independent of body mass. Participation and motivation to exercise is low in OSAS patients, with less that one third of the patients reporting regular exercise routines. We aim to investigate if aerobic interval training improves OSAS in obese subjects.
- Conditions
- Obstructive Sleep Apnea Syndrome
- Being tested
- Aerobic Interval training, Control
- Keywords
- Randomized controlled study, Exercise training, Lung function, Heart function
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Interval trainingBehavioural
Treadmill walking or running - 3 times per week for 3 months. The interval training session consists of 10 minutes warm up and continues with 4 x 4 minutes high intensity intervals at 90-95% of maximal heart rate. Training intensity will be supervised through the use of Polar pulse monitors and the BORG scale of subjective perceived exhaustion.
ControlBehavioural
Standard medical treatment
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Interval Training | Experimental | Patients randomized to training will meet for supervised aerobic interval training three times per week for 3 months. The interval training session consists of 10 minutes warm up and continues with 4 x 4 minutes of high intensity intervals at 90-95% of maximal heart rate Receives: Behavioral: Aerobic Interval training |
| Control | Other | Patients will receive standard medical treatment at the University Hospital lung department. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-hypopnea index change
Measured by Polysomnography
Measured: Baseline, 3 and 6 months
Secondary outcomes (1)
Sleep quality
Epworth Sleepiness Scale
Measured: Baseline, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionApr 2013
- Study completionOct 2013
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 Apnea SyndromeStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Trine Karlsen, PhD, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01215617
- Sponsor's protocol ID
- 2010/1539-5
- Other IDs
- 20101539-2
- Status last verified
- Mar 2017
- First submitted
- 4 Oct 2010
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karlsen T, Nes BM, Tjonna AE, Engstrom M, Stoylen A, Steinshamn S. High-intensity interval training improves obstructive sleep apnoea. BMJ Open Sport Exerc Med. 2017 Feb 8;2(1):bmjsem-2016-000155. doi: 10.1136/bmjsem-2016-000155. eCollection 2016.
PubMed 29616142
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aerobic Interval Training on Obstructive Sleep Apnea, Cardiovascular and Pulmonary Function in Obese Patients
- ClinicalTrials.gov ID
- NCT01215617
- Acronym / sponsor ID
- 2010/1539-5
- Conditions
- Obstructive Sleep Apnea Syndrome
- Keywords
- Randomized controlled study, Exercise training, Lung function, Heart function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Oct 2010 (actual)
- Primary completion
- Apr 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 6 Oct 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.
The purpose of this study is to investigate if 3 months of interval training improves obstructive sleep apnea in obese patients diagnosed with moderate to severe obstructive sleep apnea. The working hypothesis is that 3 months of 3 weekly aerobic interval training sessions improve obstructive sleep apnea and sleep quality in obese patients.
Detailed description
Obstructive sleep apnea syndrome (OSAS) is characterized by repetitive obstruction and collapse of the upper airway resulting in successive episodes of cessation of or decreased respiratory airflow, causing oxygen desaturation, awakening, loud snoring and daytime sleepiness in patients. Sleep apnea is frequently associated with co-morbidity such as obesity, diabetes, hypertension, the metabolic syndrome and cardiovascular disease. Lack of exercise is associated with OSAS severity, independent of body mass. Participation and motivation to exercise is low in OSAS patients, with less that one third of the patients reporting regular exercise routines. We aim to investigate if aerobic interval training improves OSAS in obese subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic Interval Training | Experimental | Behavioral: Aerobic Interval trainingPatients randomized to training will meet for supervised aerobic interval training three times per week for 3 months. The interval training session consists of 10 minutes warm up and continues with 4 x 4 minutes of high intensity intervals at 90-95% of maximal heart rate |
| Control | Other | Behavioral: ControlPatients will receive standard medical treatment at the University Hospital lung department. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BMI ≥ 30 kg/M2
- Apne - hypopnea index (AHI) > 10
- No significant comorbidities
- Abel to exercise
Key exclusion criteria (4 listed)
- Inability to exercise due to musculoskeletal conditions
- Known ischemic cardiovascular disease
- Drug abuse
- Mental illnesses
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 |
|---|---|---|
| Aerobic Interval trainingTreadmill walking or running - 3 times per week for 3 months. The interval training session consists of 10 minutes warm up and continues with 4 x 4 minutes high intensity intervals at 90-95% of maximal heart rate. Training intensity will be supervised through the use of Polar pulse monitors and the BORG scale of subjective perceived exhaustion. | Behavioural | Aerobic Interval Training |
| ControlStandard medical treatment | Behavioural | Control |
Primary outcome
Apnea-hypopnea index change
Time frame: Baseline, 3 and 6 months
Measured by Polysomnography
1 secondary outcome
Sleep quality
Time frame: Baseline, 3 and 6 months
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 29 Mar 2017.
- Results publication: PubMed 29616142Karlsen T, Nes BM, Tjonna AE, Engstrom M, Stoylen A, Steinshamn S. High-intensity interval training improves obstructive sleep apnoea. BMJ Open Sport Exerc Med. 2017 Feb 8;2(1):bmjsem-2016-000155. doi: 10.1136/bmjsem-2016-000155. eCollection 2016.
- Individual participant dataSharing planned: No
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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.
Trine Karlsen, PhD principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Interval training in people with Obstructive Sleep Apnea Syndrome, run by Norwegian University of Science and Technology at 1 site in Norway.
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 4 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 29 Mar 2017. 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 Norway. 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?
Apnea-hypopnea index change (time frame: Baseline, 3 and 6 months). 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 NCT01215617, 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 29 Mar 2017.