Obstructive sleep apnoea and related symptoms study

Not Applicable

Recruiting

• Conditions: Depression; Obstructive Sleep Apnoea; Mental Health - Depression; Respiratory - Sleep apnoea

• Registration Number: ACTRN12612001136897
• Lead Sponsor: ational Health and Medical Research Council Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-10-24
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

Apnoea/hypopnoea index (AHI) greater than 15

Exclusion Criteria

Central (non-obstructive) sleep apnoea.
Current or prior treatment for OSA, including: mandibular advancement splint; CPAP therapy; upper airway surgery; Provent Nasal Device (microvalve technology that provides expiratory positive airway pressure).
Participants who meet the DSM-IV diagnostic criteria for psychotic symptoms as assessed by the SCID Psychotic Screen modules B/C; or participants who meet the DSM-IV diagnostic criteria for substance abuse or co-morbid alcohol use as diagnosed by the SCID Substance Use Disorders module E,
within the 12 months prior to enrolment.
Participants who are actively suicidal as assessed by the Columbia Suicide Severity Rating Scale.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in Hamilton Depression Scale of 4 or more.[4, 8, 12 weeks following randomisation];Clinician-rated moderate or marked improvement in overall well-being from baseline as per the Clinical Global Impression scale[4, 8, 12 weeks following randomisation]

Secondary Outcome Measures

Name	Time	Method
Severity of anxiety as per the Generalised Anxiety Disorder Scale[4, 8, 12 weeks following randomisation];Epworth Sleepiness Score[1, 3, 4, 6, 8, 12 weeks following randomisation];Sleep Apnoea Quality of Lilfe Index[4, 6, 8, 12 weeks following randomisation]