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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02109237
Other study ID # HREC/13/QPCH/217
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date May 2014
Est. completion date May 2020

Study information

Verified date May 2020
Source The Prince Charles Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date May 2020
Est. primary completion date May 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Assessment of sleep disorders and treatment if required
Assessment of sleep disorders and treatment if required

Locations

Country Name City State
Australia The Prince Charles Hospital Brisbane Queensland

Sponsors (1)

Lead Sponsor Collaborator
The Prince Charles Hospital

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Other Lung function assessment Assessment of lung function to determine any variation post treatment for sleep disorder. Baseline, 6 and 12 months post sleep study
Primary To Measure Prevalence of sleep disorders in Bronchiolitis Obliterans 2&3 patients Using level one laboratory based polysomnograph 12 months
Secondary 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
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