Lifestyle Intervention in Obstructive Sleep Apnoea | NCT01546792

Studies
Lifestyle Intervention in Obstructive Sleep Apnoea

NCT01546792

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Status

Completed

Last Update Posted

Mar 7, 2012Estimated

Enrollment

60Actual

Phase

Phase 2Phase 3

Conditions

Obstructive Sleep Apnoea
Obesity

Interventions

Combined lifestyle intervention

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Feb 27, 2012

First Submission Date that Met QC Criteria

Mar 1, 2012

First Posted Date

Mar 7, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 1, 2012

Last Update Posted Date

Mar 7, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Garry Tew, Senior Research Fellow, Sheffield Teaching Hospitals NHS Foundation TrustPrincipal Investigator

Lead Sponsor

Sheffield Teaching Hospitals NHS Foundation TrustOTHER

Collaborators

Name	Class
Sheffield Hallam University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Usual care control	No Intervention	Leaflet on exercise and diet
Lifestyle intervention	Experimental	Exercise training (mixture of supervised and non-supervised) Dietary advice Behaviour change counselling (physical activity, diet)	Behavioral: Combined lifestyle intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Combined lifestyle intervention	Behavioral	Exercise training, dietary advice, behaviour change counselling	Lifestyle intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Body mass		25 weeks
Incremental shuttle walk performance		25 weeks

Secondary Outcomes

Measure	Description	Time Frame
Quality of life (EQ-5D and EQ-VAS)		13 and 25 weeks
Body fat percentage		13 and 25 weeks
Resting blood pressure

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stephen Bianchi, MD	Sheffield Teaching Hospitals NHS Foundation Trust	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre for Sport and Exercise Science, Sheffield Hallam University		Sheffield	South Yorkshire	S10 2BP	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25136550	Derived	Moss J, Tew GA, Copeland RJ, Stout M, Billings CG, Saxton JM, Winter EM, Bianchi SM. Effects of a pragmatic lifestyle intervention for reducing body mass in obese adults with obstructive sleep apnoea: a randomised controlled trial. Biomed Res Int. 2014;2014:102164. doi: 10.1155/2014/102164. Epub 2014 Jul 21.

ID	Term
D020181	Sleep Apnea, Obstructive
D009765	Obesity
D009043	Motor Activity
D012891	Sleep Apnea Syndromes

ID	Term
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic