Clinical trial NCT02109237: Sleep Disorders in Bronchiolitis Obliterans Syndrome 2&3
Official 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.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Bronchiolitis Obliterans
Sleep Disordered Breathing Central
Keywords: Lung transplantation
Bronchiolitis obliterans
Lead sponsor: The Prince Charles Hospital
Sponsor class: OTHER_GOV
First posted: 2014-04-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: Patients with Bronchiolitis Obliterans syndrome (BOS) 2 \& 3 (25) will be matched 1:2 BOS 0 patients with similar demographics such as age, gender, BMI, time post transplant and renal dysfunction.Patients fitting inclusion/exclusion criteria once they have given informed consent will complete questionnaires on quality of life (QOL), any sleep issues they may have and be assessed by a doctor. Data from standard blood tests, respiratory function tests and physio assessments of daytime activity, mobility and muscle strength will be collected. All participants will undergo an overnight sleep study. If a sleep disorder is identified the participant will be offered appropriate treatment. All assessments with the exception of the sleep study will be repeated at 6 and 12 months post sleep study.

Eligibility criteria: 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

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

Primary outcomes:
measure: To Measure Prevalence of sleep disorders in Bronchiolitis Obliterans 2&3 patients
timeFrame: 12 months
Secondary outcomes:
measure: Quality of life assessment using Rand SF36 standard survey
timeFrame: Baseline, 6 and 12 months after sleep study
Other outcomes:
measure: Assessment of daytime activity, mobility and muscle strength
timeFrame: Baseline, 6 and 12 months post sleep study
measure: Lung function assessment
timeFrame: Baseline, 6 and 12 months post sleep study
Locations:
city: Brisbane
country: Australia
facility: The Prince Charles Hospital
state: Queensland
Study officials:
affiliation: The Prince Charles Hospital
name: Andreas Fiene, BA Med,Surg. FRACP MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Prince Charles Hospital
name: James Douglas, MBBS FRACP MD
role: PRINCIPAL_INVESTIGATOR
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