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Lifestyle Intervention in Obstructive Sleep Apnoea

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01546792
Enrollment
60
Registered
2012-03-07
Start date
2010-01-31
Completion date
2011-12-31
Last updated
2012-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Obstructive Sleep Apnoea

Keywords

exercise, diet, lifestyle, sleep apnoea, obesity

Brief 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. 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.

Interventions

Exercise training, dietary advice, behaviour change counselling

Sponsors

Sheffield Hallam University
CollaboratorOTHER
Sheffield Teaching Hospitals NHS Foundation Trust
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
Body mass25 weeks
Incremental shuttle walk performance25 weeks

Secondary

MeasureTime frame
Quality of life (EQ-5D and EQ-VAS)13 and 25 weeks
Body fat percentage13 and 25 weeks
Resting blood pressure13 and 25 weeks
Blood markers (glucose, insulin, lipids, CRP)13 and 25 weeks

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026