Bronchiolitis Obliterans, Sleep Disordered Breathing Central
Conditions
Keywords
Lung transplantation, Bronchiolitis obliterans
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.
Interventions
PROCEDUREAssessment of sleep disorders and treatment if required
Assessment of sleep disorders and treatment if required
Sponsors
The Prince Charles Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Measure Prevalence of sleep disorders in Bronchiolitis Obliterans 2&3 patients | 12 months | Using level one laboratory based polysomnograph |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Australia
Outcome results
None listed