ClinicalTrials.gov
ClinicalTrials.gov Menu

Sleep Disorders in Bronchiolitis Obliterans Syndrome 2&3

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02109237
Recruitment Status : Recruiting
First Posted : April 9, 2014
Last Update Posted : May 3, 2017
Sponsor:
Information provided by (Responsible Party):
Anne Carle, The Prince Charles Hospital

April 7, 2014
April 9, 2014
May 3, 2017
May 2014
September 2018   (Final data collection date for primary outcome measure)
To Measure Prevalence of sleep disorders in Bronchiolitis Obliterans 2&3 patients [ Time Frame: 12 months ]
Using level one laboratory based polysomnograph
Same as current
Complete list of historical versions of study NCT02109237 on ClinicalTrials.gov Archive Site
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
Same as current
  • 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.
Same as current
 
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.
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.
Interventional
Not Applicable
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
  • Bronchiolitis Obliterans
  • Sleep Disordered Breathing Central
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
  • Experimental: Bronchiolitis Obliterans 2 & 3
    Assessment of sleep disorders and treatment if required
    Intervention: Procedure: Assessment of sleep disorders and treatment if required
  • Active Comparator: Bronchiolitis Obliterans 0
    Assessment of sleep disorders and treatment if required
    Intervention: Procedure: Assessment of sleep disorders and treatment if required
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
75
Same as current
September 2019
September 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Australia
 
 
NCT02109237
HREC/13/QPCH/217
Yes
Not Provided
Plan to Share IPD: Yes
Anne Carle, The Prince Charles Hospital
The Prince Charles Hospital
Not Provided
Principal Investigator: Andreas Fiene, BA Med,Surg. FRACP MD The Prince Charles Hospital
Principal Investigator: James Douglas, MBBS FRACP MD The Prince Charles Hospital
The Prince Charles Hospital
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP