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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bronchiolitis Obliterans 2 & 3 | Experimental | Assessment of sleep disorders and treatment if required |
|
| Bronchiolitis Obliterans 0 | Active Comparator | Assessment of sleep disorders and treatment if required |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Assessment of sleep disorders and treatment if required | Procedure | Assessment of sleep disorders and treatment if required |
|
| Measure | Description | Time Frame |
|---|---|---|
| To Measure Prevalence of sleep disorders in Bronchiolitis Obliterans 2&3 patients | Using level one laboratory based polysomnograph | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Lung function assessment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Fiene, BA Med,Surg. FRACP MD | The Prince Charles Hospital | Principal Investigator |
| James Douglas, MBBS FRACP MD | The Prince Charles Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Prince Charles Hospital | Brisbane | Queensland | 4032 | Australia |
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| ID | Term |
|---|---|
| D001989 | Bronchiolitis Obliterans |
| D020182 | Sleep Apnea, Central |
| ID | Term |
|---|---|
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
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|
Assessment of lung function to determine any variation post treatment for sleep disorder. |
| Baseline, 6 and 12 months post sleep study |
| D008173 |
| Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |