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Clinical Trials/ACTRN12616000203459
ACTRN12616000203459
Completed
未知

Increasing the effectiveness of treatment with continuous positive airways pressure (CPAP) using a weight-management program in overweight adults with sleep apnoea : the Sleeping Well Trial

Monash University0 sites60 target enrollmentFebruary 16, 2016

Overview

Phase
未知
Intervention
Not specified
Conditions
Sleep Apnoea
Sponsor
Monash University
Enrollment
60
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 16, 2016
End Date
May 9, 2018
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Adults aged 19\-68 years who have been newly diagnosed with moderate\-severe untreated OSA with AHI greater than 20 events/hr (AASM alternate criteria) (demonstrated by prior overnight polysomnography \[PSG]). Participants must be overweight with a body mass index (BMI) for Caucasians between 25 and 43 kg/m2 and for those of Asian and Indian descent 23 and 43 and self report a sedentary lifestyle ((self\-reported exercise less than 2 days/week and a duration of less than 45 minutes per session. Eligible participants are required to be eligible to use Fixed\-Pressure Continuous Positive Airway Pressure (CPAP).

Exclusion Criteria

  • 1\. Pregnant women
  • 2\. Diagnosed with concomitant obesity hypoventilation syndrome, Diabetes mellitus type 1, severe psychiatric disorder, and drowsiness
  • 3\. Required to use VPAP or BPAP (variable/bilevel positive airway pressure)
  • 4\. Unable to exercise (e.g. due to orthopedic or musculoskeletal problems)
  • 5\. Previous surgical or current medical treatment for OSA
  • 6\. Previous bariatric surgery
  • 7\. Current use of weight loss programs and/or weight loss drugs
  • 8\. Recent angina pectoris or atrial fibrillation
  • 9\. Insufficient knowledge of English language to be able to consent
  • 10\. Unable to provide informed consent

Outcomes

Primary Outcomes

Not specified

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