Sleep Quality in (COPD) Patients (COPD: Chronic Obstructive Pulmonary Disease)

• Conditions: COPD
• Interventions: Diagnostic Test: polysomnography; Diagnostic Test: Actigraphy; Diagnostic Test: Osler test

• Registration Number: NCT03290014
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief Summary

Patients with COPD, in addition to daytime symptoms, may suffer from nocturnal disturbances. The frequency of nocturnal problems has been reported to be higher in COPD than in the general population and it currently affects up to 50% of patients.

The CASIS questionnaire includes 7 questions and it has been recently validated as an objective tool to evaluate nocturnal symptoms in patients with asthma and COPD. The present study aims to study the validity of the CASIS questionnaire as a predictor of sleep quality measured by objective polysomnographic parameters.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-01
• Status Verified: 2017-09
• Study First Submitted: 2017-09-08
• Study First Submitted QC: 2017-09-17
• Last Update Submitted: 2017-09-17
• Study First Posted: 2017-09-21
• Last Update Posted: 2017-09-21
• Primary Completion: 2018-06-30
• Study Completion: 2018-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Good sleepers	polysomnography	COPD patients with good sleep quality according to CASIS score will be studied with polysomnography, actigraphy and OSLER test
Good sleepers	Actigraphy	COPD patients with good sleep quality according to CASIS score will be studied with polysomnography, actigraphy and OSLER test
Good sleepers	Osler test	COPD patients with good sleep quality according to CASIS score will be studied with polysomnography, actigraphy and OSLER test
Bad sleepers	polysomnography	COPD patients with poor sleep quality according to CASIS score will be studied with polysomnography, actigraphy and OSLER test
Bad sleepers	Actigraphy	COPD patients with poor sleep quality according to CASIS score will be studied with polysomnography, actigraphy and OSLER test
Bad sleepers	Osler test	COPD patients with poor sleep quality according to CASIS score will be studied with polysomnography, actigraphy and OSLER test

Primary Outcome Measures

Name	Time	Method
Sleep efficiency	One night at the sleep unit	Sleep time/Time in bed

Secondary Outcome Measures

Name	Time	Method
Total sleep time	One night at the sleep unit	Total sleep time
Arousal index	One night at the sleep unit	number of arousals/hour of sleep
sleep architecture	One night at the sleep unit	percentage of the different sleep phases
Osler test error index	Next morning after polysomnography (8a.m.--4 p.m.)	number of errors
Actigraphy	One week previous to polysomnography	Monitoring of rest/activity cycles

Trial Locations

Locations (1)

Hospital Universitari Vall d´Hebron; 🇪🇸 Barcelona, Spain