Lifestyle Intervention in Obstructive Sleep Apnoea

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01546792
• Other study ID #: STH15488
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 27, 2012
• Last updated: March 1, 2012
• Start date: January 2010
• Est. completion date: December 2011

Study information

• Verified date: March 2012
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Apnea
• Obesity
• Obstructive Sleep Apnoea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Behavioral:
• Combined lifestyle intervention
Exercise training, dietary advice, behaviour change counselling

Locations

Country	Name	City	State
United Kingdom	Centre for Sport and Exercise Science, Sheffield Hallam University	Sheffield	South Yorkshire
United Kingdom	Pulmonary Function Unit, Northern General Hospital	Sheffield	South Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield Hallam University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body mass		25 weeks	No
Primary	Incremental shuttle walk performance		25 weeks	No
Secondary	Quality of life (EQ-5D and EQ-VAS)		13 and 25 weeks	No
Secondary	Body fat percentage		13 and 25 weeks	No
Secondary	Resting blood pressure		13 and 25 weeks	No
Secondary	Blood markers (glucose, insulin, lipids, CRP)		13 and 25 weeks	No