Sleep Disorders in Bronchiolitis Obliterans Syndrome 2&3

Not Applicable

Withdrawn

• Conditions: Sleep Disordered Breathing Central; Bronchiolitis Obliterans
• Interventions: Procedure: Assessment of sleep disorders and treatment if required

• Registration Number: NCT02109237
• Lead Sponsor: The Prince Charles Hospital

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.

Study Timeline

• Study First Submitted: 2014-04-07
• Study First Submitted QC: 2014-04-08
• Study First Posted: 2014-04-09
• Study Start: 2014-05
• Status Verified: 2020-05
• Primary Completion: 2020-05
• Study Completion: 2020-05
• Last Update Submitted: 2020-05-11
• Last Update Posted: 2020-05-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bronchiolitis Obliterans 2 & 3	Assessment of sleep disorders and treatment if required	Assessment of sleep disorders and treatment if required
Bronchiolitis Obliterans 0	Assessment of sleep disorders and treatment if required	Assessment of sleep disorders and treatment if required

Primary Outcome Measures

Name	Time	Method
To Measure Prevalence of sleep disorders in Bronchiolitis Obliterans 2&3 patients	12 months	Using level one laboratory based polysomnograph

Secondary Outcome Measures

Name	Time	Method
Quality of life assessment using Rand SF36 standard survey	Baseline, 6 and 12 months after sleep study	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

Trial Locations

Locations (1)

The Prince Charles Hospital; 🇦🇺 Brisbane, Queensland, Australia