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Clinical Trials/NCT02109237
NCT02109237
Withdrawn
N/A

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.

The Prince Charles Hospital1 site in 1 countryMay 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Bronchiolitis Obliterans
Sponsor
The Prince Charles Hospital
Locations
1
Primary Endpoint
To Measure Prevalence of sleep disorders in Bronchiolitis Obliterans 2&3 patients
Status
Withdrawn
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2014
End Date
May 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Anne Carle

Dr A. Fiene & Dr J Douglas

The Prince Charles Hospital

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

Outcomes

Primary Outcomes

To Measure Prevalence of sleep disorders in Bronchiolitis Obliterans 2&3 patients

Time Frame: 12 months

Using level one laboratory based polysomnograph

Secondary Outcomes

  • Quality of life assessment using Rand SF36 standard survey(Baseline, 6 and 12 months after sleep study)

Study Sites (1)

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