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Trial registered on ANZCTR


Registration number
ACTRN12613000292774
Ethics application status
Approved
Date submitted
13/03/2013
Date registered
15/03/2013
Date last updated
19/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Cough detection and sleep abnormalities in cystic fibrosis
Scientific title
An observational study investigating the interactions between lung disease, nocturnal sleep disordered breathing and daytime function assessed by overnight polysomnography, 24 hour cough recordings and Sonomat measurements in addition to investigating if the sleep disordered breathing abnormalities are predictors of a pulmonary exacerbation in adults with cystic fibrosis.
Secondary ID [1] 282131 0
Nil
Universal Trial Number (UTN)
U1111-1140-5701
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 288615 0
Condition category
Condition code
Respiratory 288948 288948 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
For part 1 of the study, for one night, participants will perform:
1. an overnight polysomnography;
2. 24 hour cough recording;
3. sleep quality and quality of life questionnaires to measure sleep quality and overall quality of life;
4. Sonomat (a non-invasive recording device) recordings to validate the Sonomat measuring different aspects of sleep disordered breathing such as coughs, grunts, snores, shallow breathing and respiratory related arousals in cystic fibrosis.

For part 2 of the study, participants with use the Sonomat and cough recording device nightly for 3 months, or until they have had 2 exacerbations, to determine whether the Sonomat or cough recorder indicate the presence of a pulmonary exacerbation before it is noted clinically through daily diary cards and lung function measures.
Intervention code [1] 286725 0
Not applicable
Comparator / control treatment
N/A - this is an observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289074 0
Document sleep breathing abnormalities present in patients with cystic fibrosis at a time of clinical stability using overnight polysomnography and sonomat recordings.
Timepoint [1] 289074 0
Baseline
Primary outcome [2] 289075 0
Comparison of 24 hour cough recordings and Sonomat recordings with overnight polysomnography
Timepoint [2] 289075 0
Baseline
Secondary outcome [1] 301697 0
To assess if Sonomat recordings or cough recordings indicate the presence of a pulmonary exacerbation before it is noted clinically through daily diary cards and lung function measures.
Timepoint [1] 301697 0
End of 3 months or post 2 exacerbations in a patient with cystic fibrosis

Eligibility
Key inclusion criteria
1. Diagnosis of cystic fibrosis
2. Clinically stable
3. Informed consent
Minimum age
17 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Inability to comply with protocol
2. Lack of informed consent
3. Clinical instability
4. Allergy to latex

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 747 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 6535 0
2120 - Pennant Hills
Recruitment postcode(s) [2] 6536 0
2121 - Epping
Recruitment postcode(s) [3] 6537 0
2123 - Parramatta
Recruitment postcode(s) [4] 6538 0
2124 - Parramatta
Recruitment postcode(s) [5] 6539 0
2125 - West Pennant Hills
Recruitment postcode(s) [6] 6540 0
2126 - Cherrybrook
Recruitment postcode(s) [7] 6541 0
2127 - Homebush Bay
Recruitment postcode(s) [8] 6542 0
2128 - Silverwater
Recruitment postcode(s) [9] 6543 0
2129 - Sydney Markets
Recruitment postcode(s) [10] 6544 0
2130 - Summer Hill
Recruitment postcode(s) [11] 6545 0
2131 - Ashfield
Recruitment postcode(s) [12] 6546 0
2132 - Croydon
Recruitment postcode(s) [13] 6547 0
2133 - Enfield South
Recruitment postcode(s) [14] 6548 0
2134 - Burwood
Recruitment postcode(s) [15] 6549 0
2135 - Strathfield
Recruitment postcode(s) [16] 6550 0
2136 - Enfield
Recruitment postcode(s) [17] 6551 0
2137 - Cabarita
Recruitment postcode(s) [18] 6552 0
2138 - Rhodes
Recruitment postcode(s) [19] 6553 0
2140 - Homebush
Recruitment postcode(s) [20] 6554 0
2141 - Lidcombe
Recruitment postcode(s) [21] 6555 0
2142 - Granville
Recruitment postcode(s) [22] 6556 0
2143 - Regents Park
Recruitment postcode(s) [23] 6557 0
2144 - Auburn
Recruitment postcode(s) [24] 6558 0
2145 - Westmead
Recruitment postcode(s) [25] 6559 0
2146 - Toongabbie
Recruitment postcode(s) [26] 6560 0
2147 - Seven Hills
Recruitment postcode(s) [27] 6561 0
2148 - Blacktown
Recruitment postcode(s) [28] 6562 0
2150 - Harris Park
Recruitment postcode(s) [29] 6563 0
2151 - North Rocks
Recruitment postcode(s) [30] 6564 0
2153 - Baulkham Hills
Recruitment postcode(s) [31] 6565 0
2154 - Castle Hill
Recruitment postcode(s) [32] 6566 0
2156 - Glenhaven
Recruitment postcode(s) [33] 6567 0
2157 - Glenorie
Recruitment postcode(s) [34] 6568 0
2158 - Dural
Recruitment postcode(s) [35] 6569 0
2159 - Arcadia
Recruitment postcode(s) [36] 6570 0
2160 - Merrylands
Recruitment postcode(s) [37] 6571 0
2161 - Yennora
Recruitment postcode(s) [38] 6572 0
2162 - Sefton
Recruitment postcode(s) [39] 6573 0
2163 - Lansdowne
Recruitment postcode(s) [40] 6574 0
2164 - Smithfield
Recruitment postcode(s) [41] 6575 0
2165 - Fairfield
Recruitment postcode(s) [42] 6576 0
2166 - Cabramatta
Recruitment postcode(s) [43] 6577 0
2167 - Glenfield

Funding & Sponsors
Funding source category [1] 286889 0
Self funded/Unfunded
Name [1] 286889 0
Ludwig Engel Centre for Respiratory Research
Address [1] 286889 0
Department of Respiratory and Sleep Medicine
Westmead Hospital
Hawkesbury Road
Westmead NSW 2145
Country [1] 286889 0
Australia
Primary sponsor type
Individual
Name
Dr Odette Erskine
Address
Department of Respiratory and Sleep Medicine
Westmead Hospital
Hawkesbury Road
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 285677 0
Individual
Name [1] 285677 0
Associate Professor Peter Middleton
Address [1] 285677 0
Department of Respiratory and Sleep Medicine
Westmead Hospital
Hawkesbury Road
Westmead NSW 2145
Country [1] 285677 0
Australia
Secondary sponsor category [2] 285686 0
Individual
Name [2] 285686 0
Professor John Wheatley
Address [2] 285686 0
Department of Respiratory and Sleep Medicine
Westmead Hospital
Hawkesbury Road
Westmead NSW 2145
Country [2] 285686 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288948 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 288948 0
Research Office, Room 1072, Level 1, Education Block
Westmead Hospital
Hawkesbury Road
Westmead NSW 2145
Ethics committee country [1] 288948 0
Australia
Date submitted for ethics approval [1] 288948 0
Approval date [1] 288948 0
06/02/2013
Ethics approval number [1] 288948 0
HREC2012/12/4.9(3627) AU RED HREC/12/WMEAD/427

Summary
Brief summary
To determine the interactions between lung disease, nocturnal sleep disordered breathing and daytime functioning in patients with cystic fibrosis. Overnight polysomnography will be compared with cough recordings and Sonomat recordings to evaluate sleep disruptions including cough, grunting, snores, shallow breathing and respiratory related arousals in cystic fibrosis patients. In addition, the study will evaluate if the sleep abnormalities, measured non-invasively, can predict the onset of a pulmonary exacerbation in a cystic fibrosis patient.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38470 0
Dr Odette Erskine
Address 38470 0
Department of Respiratory and Sleep Medicine
Westmead Hospital
Hawkesbury Road
Westmead NSW 2145
Country 38470 0
Australia
Phone 38470 0
+61 2 8890 6797
Fax 38470 0
Email 38470 0
odette.erskine@health.nsw.gov.au
Contact person for public queries
Name 38471 0
A/Prof Peter Middleton
Address 38471 0
Department of Respiratory and Sleep Medicine
Westmead Hospital
Hawkesbury Road
Westmead NSW 2145
Country 38471 0
Australia
Phone 38471 0
+61 2 8890 6797
Fax 38471 0
Email 38471 0
peter.middleton@sydney.edu.au
Contact person for scientific queries
Name 38472 0
A/Prof Peter Middleton
Address 38472 0
Department of Respiratory and Sleep Medicine
Westmead Hospital
Hawkesbury Road
Westmead NSW 2145
Country 38472 0
Australia
Phone 38472 0
+61 2 88900 6797
Fax 38472 0
Email 38472 0
peter.middleton@sydney.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary