Clinical Trials Directory

Trials / Completed

CompletedNCT01546792

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
Phase
Phase 2 / Phase 3
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust · Academic / Other
Sex
All
Age
18 Years – 85 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALCombined lifestyle interventionExercise training, dietary advice, behaviour change counselling

Timeline

Start date
2010-01-01
Primary completion
2011-12-01
Completion
2011-12-01
First posted
2012-03-07
Last updated
2012-03-07

Locations

2 sites across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT01546792. Inclusion in this directory is not an endorsement.