Sleep Disorders in Bronchiolitis Obliterans Syndrome 2&3

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Bronchiolitis Obliterans, Sleep Disordered Breathing Central

Intervention / Treatment
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* Procedure: Assessment of sleep disorders and treatment if required


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bronchiolitis Obliterans 2 & 3<br>Assessment of sleep disorders and treatment if required | Procedure: Assessment of sleep disorders and treatment if required<br>* Assessment of sleep disorders and treatment if required<br>* Other names: Level 1 polysomnograpgh assessment and treatment if required;|
| Active Comparator: Bronchiolitis Obliterans 0<br>Assessment of sleep disorders and treatment if required | Procedure: Assessment of sleep disorders and treatment if required<br>* Assessment of sleep disorders and treatment if required<br>* Other names: Level 1 polysomnograpgh assessment and treatment if required;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Measure Prevalence of sleep disorders in Bronchiolitis Obliterans 2&3 patients | Using level one laboratory based polysomnograph | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life assessment using Rand SF36 standard survey | Participants will complete Rand SF36 standard survey for Quality of life. This will be completed at baseline visit and at 6 and 12 months post sleep study | Baseline, 6 and 12 months after sleep study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung transplantation, Bronchiolitis obliterans