Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12610000596000
Ethics application status
Not yet submitted
Date submitted
22/07/2010
Date registered
23/07/2010
Date last updated
23/07/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Sleep Disturbances in Moderate to Severe Chronic Obstructive Pulmonary Disease
Scientific title
Looking at sleep disturbances in moderate to severe Chronic Obstructive Pulmonary Disease (COPD) patients by performing a polysomnogram
Secondary ID [1] 252266 0
Nil
Universal Trial Number (UTN)
U1111-1116-1706
Trial acronym
Sleep in COPD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease (COPD) 257783 0
Sleep disturbances 257792 0
Condition category
Condition code
Respiratory 257955 257955 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Polysomnogram to observe the sleep architecture of COPD patients. Duration of observation is overnight (6pm on the first day to 7am the next morning)
Intervention code [1] 256853 0
Not applicable
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258825 0
Quantification of the extent of COPD in the patient through spirometry measurements.
Timepoint [1] 258825 0
Assessed continuously for 15-30min.
Primary outcome [2] 258832 0
Description of the sleep architecture of COPD patients. Assessed by a polysomnogram and Osler test.
Timepoint [2] 258832 0
Assessed continuously for approximately 13 hours.
Primary outcome [3] 258838 0
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.
Timepoint [3] 258838 0
Assessed for about 1 hour.
Secondary outcome [1] 264952 0
Nil
Timepoint [1] 264952 0
Nil

Eligibility
Key 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
Minimum age
40 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/08/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257312 0
University
Name [1] 257312 0
University of Melbourne
Country [1] 257312 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
University of Melbourne, VIC 3010
Country
Australia
Secondary sponsor category [1] 256557 0
Hospital
Name [1] 256557 0
Institute for Breathing and Sleep, Austin Health
Address [1] 256557 0
PO Box 5555, Studley Rd, Heidelberg, VIC 3084
Country [1] 256557 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 259339 0
Austin Health Ethics Commitee
Ethics committee address [1] 259339 0
Studley Rd, Heidelberg. VIC 3084
Ethics committee country [1] 259339 0
Australia
Date submitted for ethics approval [1] 259339 0
31/05/2010
Approval date [1] 259339 0
Ethics approval number [1] 259339 0

Summary
Brief summary
Patients with chronic obstructive pulmonary disease (COPD) have previously been shown to
complain of poor sleep, daytime fatigue and sleepiness. This has been seen in large studies
based on questionnaires, however a US study of over 2,000 participants with mild COPD found
little sleep disturbance. This study will measure sleep quality and symptoms of sleep
disturbance in a group of participants with moderate to severe COPD and correlate perceived
with actual sleep disturbance.
Thirty participants with moderate to severe COPD (defined as at least 1 standard deviation
below the lower limit of their predicted function) will complete questionnaires measuring quality
of life, symptoms of respiratory and sleep disturbance and daytime sleepiness. They will be
required to have a stable regimen of treatment for their lung disease and no significant medical
or psychological conditions which could prevent them completing the study. Standard clinical
spirometry will be performed and an in-laboratory sleep study carried out. This sleep study will
monitor sleep, airflow, oxygen and carbon dioxide (CO2) levels during the night, as
accumulation of CO2 during the night in these patients may contribute to sleep disruption and
fragmentation. Participants will be asked to describe the quality of their sleep and this will be
compared to the measured sleep, as sleep perception is thought to be poor in these patients.
The outcomes of the study will be a description of sleep architecture, including the number of
changes in sleep stage. It is thought that sleep stage transitions are important for daytime
sleepiness. The degree of sleep fragmentation will be correlated with the sleep questionnaire
outcomes and also with the severity and other measures of the respiratory function.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31417 0
Address 31417 0
Country 31417 0
Phone 31417 0
Fax 31417 0
Email 31417 0
Contact person for public queries
Name 14664 0
Dr Maree Barnes
Address 14664 0
Austin Health
145 Studley Rd
PO Box 5555
Heidelberg VIC 3084
Country 14664 0
Australia
Phone 14664 0
+613 9496 3688
Fax 14664 0
Email 14664 0
maree.barnes@austin.org.au
Contact person for scientific queries
Name 5592 0
Mr Danny Brazzale
Address 5592 0
Austin Health
145 Studley Rd
PO Box 5555
Heidelberg VIC 3084
Country 5592 0
Australia
Phone 5592 0
+613 9496 5786
Fax 5592 0
Email 5592 0
danny.brazzale@austin.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.