Sleep Disturbances in Moderate to Severe Chronic Obstructive Pulmonary Disease

Not Applicable

• Conditions: Chronic Obstructive Pulmonary Disease (COPD); Sleep disturbances; Respiratory - Chronic obstructive pulmonary disease

• Registration Number: ACTRN12610000596000
• Lead Sponsor: niversity of Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-07-23
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Previous diagnosis of COPD
Forced expiratory volume in 1 second (FEV1)/Forced vital capacity(FVC) below lower limit of normal range
Forced expiratory volume in 1 second(FEV1) less than 70% mean predicted value
Body Mass Index less than or equal to 33
10 pack year history of smoking

Exclusion Criteria

Change in COPD medication within past 30 days
Previously diagnosed or treated sleep disordered breathing
Significant neurological, psychological or psychiatric co-morbidities
Unable to refrain from caffeine from 4pm on night of sleep study
Unable to refrain from cigarettes during overnight stay (6pm to 7am the following day)
Unable to refrain from alcohol from 12pm on day of sleep study

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quantification of the extent of COPD in the patient through spirometry measurements.[Assessed continuously for 15-30min.];Description of the sleep architecture of COPD patients. Assessed by a polysomnogram and Osler test.[Assessed continuously for approximately 13 hours.];Patient's perceived sleepiness and quality of life. Assessed by questionnaires on the patient's perceived sleepiness and quality of life. Questionnaires used: Chronic Respiratory Disease Questionnaire (CRDQ), Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), Modified Medical Research Council Dyspnoea Scale (MMRC), Nottingham Health Profile (NHP), Short Form-36 Medical Outcomes Survey (SF36) and Profile of Mood States.[Assessed for about 1 hour.]

Secondary Outcome Measures

Name	Time	Method
il[Nil]