Sleep Disorders in Bronchiolitis Obliterans Syndrome 2&3

Sponsor

The Prince Charles Hospital (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02109237

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bronchiolitis Obliterans Sleep Disordered Breathing Central	Procedure: Assessment of sleep disorders and treatment if required	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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.

Study Start Date :

May 1, 2014

Actual Primary Completion Date :

May 1, 2020

Actual Study Completion Date :

May 1, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Assessment of daytime activity, mobility and muscle strength [Baseline, 6 and 12 months post sleep study]
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
Lung function assessment [Baseline, 6 and 12 months post sleep study]
Assessment of lung function to determine any variation post treatment for sleep disorder.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Prince Charles Hospital	Brisbane	Queensland	Australia	4032

Sponsors and Collaborators

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