Lifestyle Intervention in Obstructive Sleep Apnoea

March 1, 2012 updated by: Garry Tew, Sheffield Teaching Hospitals NHS Foundation Trust

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom, S10 2BP
        • Centre for Sport and Exercise Science, Sheffield Hallam University
      • Sheffield, South Yorkshire, United Kingdom, S57AU
        • Pulmonary Function Unit, Northern General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual care control
Leaflet on exercise and diet
Experimental: Lifestyle intervention
Exercise training (mixture of supervised and non-supervised) Dietary advice Behaviour change counselling (physical activity, diet)
Behavioral: Combined lifestyle intervention
Exercise training, dietary advice, behaviour change counselling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Body mass
Time Frame: 25 weeks
25 weeks
Incremental shuttle walk performance
Time Frame: 25 weeks
25 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life (EQ-5D and EQ-VAS)
Time Frame: 13 and 25 weeks
13 and 25 weeks
Body fat percentage
Time Frame: 13 and 25 weeks
13 and 25 weeks
Resting blood pressure
Time Frame: 13 and 25 weeks
13 and 25 weeks
Blood markers (glucose, insulin, lipids, CRP)
Time Frame: 13 and 25 weeks
13 and 25 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Collaborators

Sheffield Hallam University

Investigators

  • Principal Investigator: Stephen Bianchi, MD, Sheffield Teaching Hospitals NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

February 27, 2012

First Submitted That Met QC Criteria

March 1, 2012

First Posted (Estimate)

March 7, 2012

Study Record Updates

Last Update Posted (Estimate)

March 7, 2012

Last Update Submitted That Met QC Criteria

March 1, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STH15488

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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