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Lifestyle Intervention in Obstructive Sleep Apnoea

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ClinicalTrials.gov Identifier: NCT01546792
Recruitment Status : Completed
First Posted : March 7, 2012
Last Update Posted : March 7, 2012
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnoea Obesity Behavioral: Combined lifestyle intervention Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : January 2010
Primary Completion Date : December 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. Body mass [ Time Frame: 25 weeks ]
  2. Incremental shuttle walk performance [ Time Frame: 25 weeks ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01546792

United Kingdom
Centre for Sport and Exercise Science, Sheffield Hallam University
Sheffield, South Yorkshire, United Kingdom, S10 2BP
Pulmonary Function Unit, Northern General Hospital
Sheffield, South Yorkshire, United Kingdom, S57AU
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield Hallam University
Principal Investigator: Stephen Bianchi, MD Sheffield Teaching Hospitals NHS Foundation Trust
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Garry Tew, Senior Research Fellow, Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01546792     History of Changes
Other Study ID Numbers: STH15488
First Posted: March 7, 2012    Key Record Dates
Last Update Posted: March 7, 2012
Last Verified: March 2012

Keywords provided by Garry Tew, Sheffield Teaching Hospitals NHS Foundation Trust:
sleep apnoea

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases