Skip to main content
OpenTrials
Completed

NCT Number: NCT01546792

Lifestyle Intervention in Obstructive Sleep Apnoea

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Centre for Sport and Exercise Science, Sheffield Hallam University, Sheffield, South Yorkshire, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Combined lifestyle intervention

Behavioral

Exercise training, dietary advice, behaviour change counselling

Primary outcomes

  1. Body mass

    Time frame: 25 weeks

  2. Incremental shuttle walk performance

    Time frame: 25 weeks

Secondary outcomes

  1. Quality of life (EQ-5D and EQ-VAS)

    Time frame: 13 and 25 weeks

  2. Body fat percentage

    Time frame: 13 and 25 weeks

  3. Resting blood pressure

    Time frame: 13 and 25 weeks

  4. Blood markers (glucose, insulin, lipids, CRP)

    Time frame: 13 and 25 weeks

Sponsors and collaborators

Lead sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Other

Collaborators

  • Sheffield Hallam University

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 7, 2012
Registry last updated
Mar 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.