Obstructive Sleep ApnoeaPhase 2/3NCT01546792
Lifestyle Intervention in Obstructive Sleep Apnoea
A Phase 2/3 study testing Combined lifestyle intervention in people with Obstructive Sleep Apnoea and Obesity, run by Sheffield Teaching Hospitals NHS Foundation Trust at 2 sites in United Kingdom.
Trial summary
Obstructive sleep apnoea/hypopnoea syndrome (OSAHS) is a common disorder characterised by interrupted breathing while sleeping. It is associated with cardiovascular problems such as high blood pressure, heart attack and stroke. Furthermore, most patients with OSAHS are overweight and have impaired quality of life. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Obstructive Sleep Apnoea, Obesity
- What is being tested?
- Combined lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jan 2010to Dec 2011
- Phase
- Phase 2/3
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- obstructive sleep apnoea patients who have been receiving CPAP therapy for at least 6 months and are known to be adherent to the treatment (>75% nightly use per week)
- clinically obese (body mass index >30)
- age 18-85 years
- able to undertake exercise testing and training
Who cannot join
- patients with any contraindications to exercise (e.g. severe hypertension, unstable arrhythmias, severe musculoskeletal injuries)
- unable to undertake the requirements of the study
- non-English speaking
- already undertaking >30 min exercise >3 times per week
- non-compliant with CPAP
- body mass index <30
- unable to provide written informed consent
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Centre for Sport and Exercise Science, Sheffield Hallam University
Sheffield, South Yorkshire, S10 2BP
Pulmonary Function Unit, Northern General Hospital
Sheffield, South Yorkshire, S57AU
About this study
Official title: Effects of a Lifestyle Intervention on Quality of Life, Weight Loss and Cardiovascular Risk in Patients With Obstructive Sleep Apnoea Established on Continuous Positive Airway Pressure
Obstructive sleep apnoea/hypopnoea syndrome (OSAHS) is a common disorder characterised by interrupted breathing while sleeping. It is associated with cardiovascular problems such as high blood pressure, heart attack and stroke. Furthermore, most patients with OSAHS are overweight and have impaired quality of life. Lifestyle interventions incorporating exercise training, dietary advice and behaviour change have been shown to elicit favourable changes in quality of life, body mass/composition and cardiovascular risk in a range of patient groups. However, no study has investigated the impact of lifestyle modification on such health outcomes in patients with OSAHS. This study will address this issue by investigating the effects of a lifestyle intervention on quality of life, body mass/composition and cardiovascular risk in patients with OSAHS. A total of 60 volunteers will be recruited and randomly allocated to one of the two groups. Patients in the intervention group will be offered a 12-week individualised lifestyle programme consisting of supervised exercise training, dietary advice and behaviour change counselling. Patients in the control group will receive an educational booklet detailing healthy eating and exercise guidelines but no supervised or structured intervention. The results of this study will inform the design of a larger, multi-centre randomised controlled trial.
- Conditions
- Obstructive Sleep Apnoea, Obesity
- Being tested
- Combined lifestyle intervention
- Keywords
- exercise, diet, lifestyle, sleep apnoea, obesity
- Medical subject headings
- Sleep Apnea, Obstructive, Obesity, Motor Activity, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined lifestyle interventionBehavioural
Exercise training, dietary advice, behaviour change counselling
| Study group | Role | What they receive |
|---|---|---|
| Usual care control | No intervention | Leaflet on exercise and diet |
| Lifestyle intervention | Experimental | Exercise training (mixture of supervised and non-supervised) Dietary advice Behaviour change counselling (physical activity, diet) Receives: Behavioral: Combined lifestyle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass
Measured: 25 weeks
Incremental shuttle walk performance
Measured: 25 weeks
Secondary outcomes (4)
Quality of life (EQ-5D and EQ-VAS)
Measured: 13 and 25 weeks
Body fat percentage
Measured: 13 and 25 weeks
Resting blood pressure
Measured: 13 and 25 weeks
Blood markers (glucose, insulin, lipids, CRP)
Measured: 13 and 25 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startJan 2010
- Primary completionDec 2011
- Study completionDec 2011
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 ApnoeaStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Sheffield Hallam University
- Responsible party
- Principal investigator, Garry Tew, Sheffield Teaching Hospitals NHS Foundation Trust
- Investigators
- Stephen Bianchi, MD, Principal investigator, Sheffield Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01546792
- Sponsor's protocol ID
- STH15488
- Status last verified
- Mar 2012
- First submitted
- 27 Feb 2012
- Last updated
- 7 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Moss J, Tew GA, Copeland RJ, Stout M, Billings CG, Saxton JM, Winter EM, Bianchi SM. Effects of a pragmatic lifestyle intervention for reducing body mass in obese adults with obstructive sleep apnoea: a randomised controlled trial. Biomed Res Int. 2014;2014:102164. doi: 10.1155/2014/102164. Epub 2014 Jul 21.
PubMed 25136550
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Lifestyle Intervention on Quality of Life, Weight Loss and Cardiovascular Risk in Patients With Obstructive Sleep Apnoea Established on Continuous Positive Airway Pressure
- ClinicalTrials.gov ID
- NCT01546792
- Acronym / sponsor ID
- STH15488
- Conditions
- Obstructive Sleep Apnoea, Obesity
- Keywords
- exercise, diet, lifestyle, sleep apnoea, obesity
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Sheffield Hallam University
- Study start
- Jan 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 7 Mar 2012 (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.
Obstructive sleep apnoea/hypopnoea syndrome (OSAHS) is a common disorder characterised by interrupted breathing while sleeping. It is associated with cardiovascular problems such as high blood pressure, heart attack and stroke. Furthermore, most patients with OSAHS are overweight and have impaired quality of life. Lifestyle interventions incorporating exercise training, dietary advice and behaviour change have been shown to elicit favourable changes in quality of life, body mass/composition and cardiovascular risk in a range of patient groups. However, no study has investigated the impact of lifestyle modification on such health outcomes in patients with OSAHS. This study will address this issue by investigating the effects of a lifestyle intervention on quality of life, body mass/composition and cardiovascular risk in patients with OSAHS. A total of 60 volunteers will be recruited and randomly allocated to one of the two groups. Patients in the intervention group will be offered a 12-week individualised lifestyle programme consisting of supervised exercise training, dietary advice and behaviour change counselling. Patients in the control group will receive an educational booklet detailing healthy eating and exercise guidelines but no supervised or structured intervention. The results of this study will inform the design of a larger, multi-centre randomised controlled trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care control | No intervention | –Leaflet on exercise and diet |
| Lifestyle intervention | Experimental | Behavioral: Combined lifestyle interventionExercise training (mixture of supervised and non-supervised) Dietary advice Behaviour change counselling (physical activity, diet) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- obstructive sleep apnoea patients who have been receiving CPAP therapy for at least 6 months and are known to be adherent to the treatment (>75% nightly use per week)
- clinically obese (body mass index >30)
- age 18-85 years
- able to undertake exercise testing and training
Key exclusion criteria (7 listed)
- patients with any contraindications to exercise (e.g. severe hypertension, unstable arrhythmias, severe musculoskeletal injuries)
- unable to undertake the requirements of the study
- non-English speaking
- already undertaking >30 min exercise >3 times per week
- non-compliant with CPAP
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 |
|---|---|---|
| Combined lifestyle interventionExercise training, dietary advice, behaviour change counselling | Behavioural | Lifestyle intervention |
Primary outcome
Body mass
Time frame: 25 weeks
Incremental shuttle walk performance
Time frame: 25 weeks
4 secondary outcomes
Quality of life (EQ-5D and EQ-VAS)
Time frame: 13 and 25 weeks
Body fat percentage
Time frame: 13 and 25 weeks
Resting blood pressure
Time frame: 13 and 25 weeks
Blood markers (glucose, insulin, lipids, CRP)
Time frame: 13 and 25 weeks
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 7 Mar 2012.
- Derived from this study: PubMed 25136550Moss J, Tew GA, Copeland RJ, Stout M, Billings CG, Saxton JM, Winter EM, Bianchi SM. Effects of a pragmatic lifestyle intervention for reducing body mass in obese adults with obstructive sleep apnoea: a randomised controlled trial. Biomed Res Int. 2014;2014:102164. doi: 10.1155/2014/102164. Epub 2014 Jul 21.
Related trials for Obstructive Sleep Apnoea
RecruitingObservational study
Development and Clinical Validation of Artificial Intelligence Algorithms for Sleep Staging and Obstructive Sleep Apnea Screening Based on a Large-Scale Model Trained on Multimodal Physiological Signals From Diverse Populations
Sleep Apnea, Obstructive, Sleep Staging
RecruitingObservational study
Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
Pediatric Obstructive Sleep Apnea
Not yet recruiting
Effect of High-flow Nasal Cannula Oxygenation on the Incidence of Hypoxemia During Painless Gastrointestinal Endoscopy in Patients at High Risk for Obstructive Sleep Apnea Syndrome in High-altitude Regions
Hypoxemia, Gastric Cancer (Diagnosis)
Not yet recruitingPhase 2
Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
Obesity & Overweight, Respiratory Depression
Enrolling by invitation
Myofunctional Therapy for Obstructive Sleep Apnea
Obstructive Sleep Apnea
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.
Stephen Bianchi, MD principal investigator
Sheffield Teaching Hospitals NHS Foundation Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Combined lifestyle intervention in people with Obstructive Sleep Apnoea and Obesity, run by Sheffield Teaching Hospitals NHS Foundation Trust at 2 sites in United Kingdom.
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 7 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 7 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Body mass (time frame: 25 weeks). 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 NCT01546792, 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 7 Mar 2012.