Flinders Chronic Condition Self-managment Program for Weight Loss in Obstructive Sleep Apnoea study

Not Applicable

Recruiting

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

• Registration Number: ACTRN12615001117505
• Lead Sponsor: Dr Ching Li Chai-Coetzer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-23
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Moderate to severe obstructive sleep apnoea defined as an Apnea Hypopnea Index (AHI) of 20/hour or more,
Body Mass Index of 30 or more,
ESS (Epworth Sleepiness Scale) score of 8 or more,
Age 18-70, and
Ability to give voluntary written consent and to complete English-language self-report instruments.

Exclusion Criteria

Severe morbid obesity (body mass index [BMI]; neuromuscular disease; unstable psychiatric disease or cognitive impairment considered likely to interfere with adherence to instructions, completing the study or managing CPAP; hospitalization in the previous 3 months for myocardial infarction, unstable angina, cardiac failure, or cerebrovascular accident or New York Heart Association class III or IV symptoms; and lung disease with awake resting oxygen saturation of less than 92%). Patients who are pregnant, or are current participants in other research studies also will not be included.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Body weight (Kg) change (compared to baseline prior to commencement of intervention); assessed by research personnel using weighing scales at the AISH [3 and 6 months after intervention commencement];Body Mass Index (BMI) assessed via weight and height measurements calculated into a formula for BMI[at 3 and 6 months after intervention commencement ];Abdominal girth (cm) measured via measuring tape.[at 0 months and 6 months post commencement of study]

Secondary Outcome Measures

Name	Time	Method
Daytime sleepiness as measured by the Epworth Sleepiness Scale (ESS) [3 and 6 months after intervention commencement];Apnea Hypopnea Index (AHI)[3 and 6 months after intervention commencement];Continuous positive airway pressure (CPAP) treatment adherence assessed by downloaded CPAP adherence data from participant's CPAP machine (if undergoing CPAP treatment).[3 and 6 months after intervention commencement];Reaction time assessed by Psychomotor Vigilance Test (PVT) [at 3 and 6 months post intervention commencement];Blood Pressure measurements by sphygmomanometer.[at 3 and 6 months post intervention commencement]