Sleep Disorders in Bronchiolitis Obliterans Syndrome 2&3

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.

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.

Study Overview

• Status: Withdrawn
• Conditions: Bronchiolitis Obliterans; Sleep Disordered Breathing Central
• Intervention / Treatment: Procedure: Assessment of sleep disorders and treatment if required

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Brisbane, Queensland, Australia, 4032
      • The Prince Charles Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Bronchiolitis Obliterans 2 & 3; Assessment of sleep disorders and treatment if required	Procedure: Assessment of sleep disorders and treatment if required; Assessment of sleep disorders and treatment if required; Other Names: Level 1 polysomnograpgh assessment and treatment if required
ACTIVE_COMPARATOR: Bronchiolitis Obliterans 0; Assessment of sleep disorders and treatment if required	Procedure: Assessment of sleep disorders and treatment if required; Assessment of sleep disorders and treatment if required; Other Names: Level 1 polysomnograpgh assessment and treatment if required

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of daytime activity, mobility and muscle strength	As part of standard care transplant patients are assessed for daytime activity, mobility and muscle strength every 6months this data will be used to assess any changes post treatment for sleep disorders	Baseline, 6 and 12 months post sleep study
Lung function assessment	Assessment of lung function to determine any variation post treatment for sleep disorder.	Baseline, 6 and 12 months post sleep study

Collaborators and Investigators

• Sponsor: The Prince Charles Hospital
• Investigators: Principal Investigator: Andreas Fiene, BA Med,Surg. FRACP MD, The Prince Charles Hospital; Principal Investigator: James Douglas, MBBS FRACP MD, The Prince Charles Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (ACTUAL): May 1, 2020
• Study Completion (ACTUAL): May 1, 2020

Study Registration Dates

• First Submitted: April 7, 2014
• First Submitted That Met QC Criteria: April 8, 2014
• First Posted (ESTIMATE): April 9, 2014

Study Record Updates

• Last Update Posted (ACTUAL): May 13, 2020
• Last Update Submitted That Met QC Criteria: May 11, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Lung transplantation; Bronchiolitis obliterans
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Lung Diseases; Neurologic Manifestations; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Sleep Apnea Syndromes; Sleep Wake Disorders; Parasomnias; Bronchiolitis; Bronchiolitis Obliterans
• Other Study ID Numbers: HREC/13/QPCH/217

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES