Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02109237




Registration number
NCT02109237
Ethics application status
Date submitted
7/04/2014
Date registered
9/04/2014
Date last updated
13/05/2020

Titles & IDs
Public title
Sleep Disorders in Bronchiolitis Obliterans Syndrome 2&3
Scientific title
The Prevalence and Treatment of Sleep Disorders in Lung Transplant Recipients With BOS 2 & 3 and the Influence on Quality of Life and Daytime Activity.
Secondary ID [1] 0 0
HREC/13/QPCH/217
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bronchiolitis Obliterans 0 0
Sleep Disordered Breathing Central 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Respiratory 0 0 0 0
Sleep apnoea
Neurological 0 0 0 0
Other neurological disorders
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Assessment of sleep disorders and treatment if required

Experimental: Bronchiolitis Obliterans 2 & 3 - Assessment of sleep disorders and treatment if required

Active comparator: Bronchiolitis Obliterans 0 - Assessment of sleep disorders and treatment if required


Treatment: Surgery: Assessment of sleep disorders and treatment if required
Assessment of sleep disorders and treatment if required
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To Measure Prevalence of sleep disorders in Bronchiolitis Obliterans 2&3 patients
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Quality of life assessment using Rand SF36 standard survey
Timepoint [1] 0 0
Baseline, 6 and 12 months after sleep study

Eligibility
Key inclusion criteria
* Patients who are post lung, heart lung and heart lung liver transplant with bronchiolitis obliterans 2 & 3
* Comparative group -Patients who are post lung, heart lung and heart lung liver transplant with bronchiolitis obliterans 0
* Identified possible sleep related disorder
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subjects who do not provide informed consent
* Subjects unable to understand the study and related procedures
* Patients with a life expectancy of less than 6 months

Study design
Purpose of the study
Other
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/05/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2020
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
The Prince Charles Hospital - Brisbane
Recruitment postcode(s) [1] 0 0
4032 - Brisbane

Funding & Sponsors
Primary sponsor type
Government body
Name
The Prince Charles Hospital
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study is to determine whether sleep disorders contribute to impaired quality of life and mobility in patients with Bronchiolitis Obliterans syndrome and whether non invasive positive airways pressure ventilation can improve sleep, quality of life and mobility in this patient group.
Trial website
https://clinicaltrials.gov/study/NCT02109237
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andreas Fiene, BA Med,Surg. FRACP MD
Address 0 0
The Prince Charles Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02109237