Sleep Disorders in Bronchiolitis Obliterans Syndrome 2&3

The Prince Charles Hospital

Status: Withdrawn

Conditions: Bronchiolitis Obliterans; Sleep Disordered Breathing Central

Treatments: Procedure: Assessment of sleep disorders and treatment if required

Study type: Interventional

Funder types: Other

Identifiers

NCT02109237

HREC/13/QPCH/217

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Bronchiolitis Obliterans 2 & 3

Experimental group

Description:

Assessment of sleep disorders and treatment if required

Treatment:

Procedure: Assessment of sleep disorders and treatment if required

Bronchiolitis Obliterans 0

Active Comparator group

Description:

Assessment of sleep disorders and treatment if required

Treatment:

Procedure: Assessment of sleep disorders and treatment if required