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Sleep Disorders in Bronchiolitis Obliterans Syndrome 2&3

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by The Prince Charles Hospital
Sponsor:
Information provided by (Responsible Party):
Anne Carle, The Prince Charles Hospital
ClinicalTrials.gov Identifier:
NCT02109237
First received: April 7, 2014
Last updated: April 29, 2015
Last verified: April 2015
  Purpose
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 Intervention
Bronchiolitis Obliterans
Sleep Disordered Breathing Central
Procedure: Assessment of sleep disorders and treatment if required

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by The Prince Charles Hospital:

Primary Outcome Measures:
  • To Measure Prevalence of sleep disorders in Bronchiolitis Obliterans 2&3 patients [ Time Frame: 12 months ]
    Using level one laboratory based polysomnograph


Secondary Outcome Measures:
  • Quality of life assessment using Rand SF36 standard survey [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline, 6 and 12 months post sleep study ]
    Assessment of lung function to determine any variation post treatment for sleep disorder.


Estimated Enrollment: 75
Study Start Date: May 2014
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Level 1 polysomnograpgh assessment 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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02109237

Locations
Australia, Queensland
The Prince Charles Hospital Recruiting
Brisbane, Queensland, Australia, 4032
Contact: Andreas Fiene, BA Med, Surg FRACP MD    +61 07 31394000    andreas.fiene@health.qld.gov.au   
Contact: James Douglas, MBBS FRACP MD    +61 07 3139 4000    james.douglas@health.qld.gov.au   
Principal Investigator: Andreas Fiene, BA Med Surg FRACP MD         
Principal Investigator: James Douglas, MBBS FRACP MD         
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
  More Information

Responsible Party: Anne Carle, Dr A. Fiene & Dr J Douglas, The Prince Charles Hospital
ClinicalTrials.gov Identifier: NCT02109237     History of Changes
Other Study ID Numbers: HREC/13/QPCH/217
Study First Received: April 7, 2014
Last Updated: April 29, 2015

Keywords provided by The Prince Charles Hospital:
Lung transplantation
Bronchiolitis obliterans

Additional relevant MeSH terms:
Bronchiolitis
Sleep Wake Disorders
Parasomnias
Bronchiolitis Obliterans
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on March 28, 2017