Sleep, Lifestyle, Energy, Eating, Exercise Program for the management of sleep apnea patients indicated for weight loss treatment: A randomised, controlled pilot study.

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnoea; Obesity; Respiratory - Sleep apnoea; Diet and Nutrition - Obesity

• Registration Number: ACTRN12613000191796
• Lead Sponsor: The Woolcock Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-02-18
• Study Completion: 2014-09-08
• Last Update Posted: 9 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

The following inclusion criteria enable the volunteer to participate in the SLEEEP Study:
Males & Females aged 18-65 years.

General or central obesity: BMI: greater than or equal to 30kg/m2 (greater than or equal to 26kg/m2 amongst non-Europeans) or waist circumference greater than or equal to 88cm for women and greater than or equal to 102cm for men (greater than or equal to 90cm in men and greater than or equal to 80cm in women who are non-European).

Willing and medically able to participate in a supervised very low energy diet (Optifast) and the dietary and lifestyle modification groups for a 12 month period.

Mild-severe, symptomatic OSA (degree of symptoms at the treating physician’s discretion based on overnight sleep study report)

No history of or current presence of eating disorders , significant/extensive food allergies or significant food intolerances (e.g. coeliac disease)

Willing and able to complete all assessments outlined in participant information sheet

Hold a current driver’s license or have access to transport.

Exclusion Criteria

Unstable aortic aneurysm
Rapidly progressive or terminal illness
Severe left ventricular dysfunction/end stage congestive heart failure
Severe aortic stenosis
Severe psychosis or behavioural disturbance or cognitive impairment
Patients known to be involved in illegal activity

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in waist circumference (measured in cm)<br>This outcome was ethically approved on 1/3/16.[Change between 2 and 12 months]