Sleep Disorders in Bronchiolitis Obliterans Syndrome 2&3

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2020-05-31

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.

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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.

Conditions

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Bronchiolitis Obliterans Sleep Disordered Breathing Central

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Bronchiolitis Obliterans 2 & 3

Assessment of sleep disorders and treatment if required

Group Type EXPERIMENTAL

Assessment of sleep disorders and treatment if required

Intervention Type PROCEDURE

Assessment of sleep disorders and treatment if required

Bronchiolitis Obliterans 0

Assessment of sleep disorders and treatment if required

Group Type ACTIVE_COMPARATOR

Assessment of sleep disorders and treatment if required

Intervention Type PROCEDURE

Assessment of sleep disorders and treatment if required

Interventions

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Assessment of sleep disorders and treatment if required

Intervention Type PROCEDURE

Other Intervention Names

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Level 1 polysomnograpgh assessment and treatment if required

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No