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Clinical Trials/ACTRN12613000191796
ACTRN12613000191796
Completed
未知

Weight loss lifestyle intervention for obese adults with sleep apnea to investigate the effect of treatment on sympathetic activity and cardio-metabolic outcomes.

The Woolcock Institute0 sites42 target enrollmentFebruary 18, 2013
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ConditionsObstructive Sleep ApnoeaObesityRespiratory - Sleep apnoeaDiet and Nutrition - Obesity

Overview

Phase
未知
Intervention
Not specified
Conditions
Obstructive Sleep Apnoea
Sponsor
The Woolcock Institute
Enrollment
42
Status
Completed
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 18, 2013
End Date
September 8, 2014
Last Updated
3 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
The Woolcock Institute

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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