NCT02109237

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2014

Completed
22 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

May 13, 2020

Status Verified

May 1, 2020

Enrollment Period

6 years

First QC Date

April 7, 2014

Last Update Submit

May 11, 2020

Conditions

Bronchiolitis ObliteransSleep Disordered Breathing Central

Keywords

Lung transplantationBronchiolitis obliterans

Outcome Measures

Primary Outcomes (1)

  • To Measure Prevalence of sleep disorders in Bronchiolitis Obliterans 2&3 patients

    Using level one laboratory based polysomnograph

    12 months

Secondary Outcomes (1)

  • Quality of life assessment using Rand SF36 standard survey

    Baseline, 6 and 12 months after sleep study

Other Outcomes (2)

  • Assessment of daytime activity, mobility and muscle strength

    Baseline, 6 and 12 months post sleep study

  • Lung function assessment

    Baseline, 6 and 12 months post sleep study

Study Arms (2)

Bronchiolitis Obliterans 2 & 3

EXPERIMENTAL

Assessment of sleep disorders and treatment if required

Procedure: Assessment of sleep disorders and treatment if required

Bronchiolitis Obliterans 0

ACTIVE COMPARATOR

Assessment of sleep disorders and treatment if required

Procedure: Assessment of sleep disorders and treatment if required

Interventions

Assessment of sleep disorders and treatment if requiredPROCEDURE

Assessment of sleep disorders and treatment if required

Also known as: Level 1 polysomnograpgh assessment and treatment if required
Bronchiolitis Obliterans 0Bronchiolitis Obliterans 2 & 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Prince Charles Hospital

Brisbane, Queensland, 4032, Australia

Location

MeSH Terms

Conditions

Bronchiolitis ObliteransSleep Apnea, Central

Condition Hierarchy (Ancestors)

BronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesSleep Apnea SyndromesApneaRespiration DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Andreas Fiene, BA Med,Surg. FRACP MD

    The Prince Charles Hospital

    PRINCIPAL INVESTIGATOR

  • James Douglas, MBBS FRACP MD

    The Prince Charles Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr A. Fiene & Dr J Douglas

Study Record Dates

First Submitted

April 7, 2014

First Posted

April 9, 2014

Study Start

May 1, 2014

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

May 13, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will share

Locations

AU(1)