Bronchiolitis ObliteransNCT02109237
Sleep Disorders in Bronchiolitis Obliterans Syndrome 2&3
A study testing Assessment of sleep disorders and treatment if required in people with Bronchiolitis Obliterans and Sleep Disordered Breathing Central, run by The Prince Charles Hospital at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiolitis Obliterans, Sleep Disordered Breathing Central
- What is being tested?
- Assessment of sleep disorders and treatment if required
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteAustralia
- Study dates
- May 2014to May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Assessment of sleep disorders and treatment if required
- Keywords
- Lung transplantation, Bronchiolitis obliterans
- Medical subject headings
- Bronchiolitis Obliterans, Sleep Apnea, Central
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of sleep disorders and treatment if requiredProcedure or surgery
Also called Level 1 polysomnograpgh assessment and treatment if required
Assessment of sleep disorders and treatment if required
| Study group | Role | What they receive |
|---|---|---|
| Bronchiolitis Obliterans 2 & 3 | Experimental | Assessment of sleep disorders and treatment if required Receives: Procedure: Assessment of sleep disorders and treatment if required |
| Bronchiolitis Obliterans 0 | Active comparator | Assessment of sleep disorders and treatment if required Receives: Procedure: Assessment of sleep disorders and treatment if required |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Measure Prevalence of sleep disorders in Bronchiolitis Obliterans 2&3 patients
Using level one laboratory based polysomnograph
Measured: 12 months
Secondary outcomes (1)
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
Measured: Baseline, 6 and 12 months after sleep study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2020
- Study completionMay 2020
Why it stopped: no funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchiolitis ObliteransStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Prince Charles Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Anne Carle, The Prince Charles Hospital
- Investigators
- Andreas Fiene, BA Med,Surg. FRACP MD, Principal investigator, The Prince Charles HospitalJames Douglas, MBBS FRACP MD, Principal investigator, The Prince Charles Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02109237
- Sponsor's protocol ID
- HREC/13/QPCH/217
- Status last verified
- May 2020
- First submitted
- 7 Apr 2014
- Last updated
- 13 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT02109237
- Acronym / sponsor ID
- HREC/13/QPCH/217
- Keywords
- Lung transplantation, Bronchiolitis obliterans
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Prince Charles HospitalOther government
- Study start
- May 2014
- Primary completion
- May 2020 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 9 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bronchiolitis Obliterans 2 & 3 | Experimental | Procedure: Assessment of sleep disorders and treatment if requiredAssessment of sleep disorders and treatment if required |
| Bronchiolitis Obliterans 0 | Active comparator | Procedure: Assessment of sleep disorders and treatment if requiredAssessment of sleep disorders and treatment if required |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of sleep disorders and treatment if requiredAlso: Level 1 polysomnograpgh assessment and treatment if requiredAssessment of sleep disorders and treatment if required | Procedure or surgery | Bronchiolitis Obliterans 0, Bronchiolitis Obliterans 2 & 3 |
Primary outcome
To Measure Prevalence of sleep disorders in Bronchiolitis Obliterans 2&3 patients
Time frame: 12 months
Using level one laboratory based polysomnograph
1 secondary outcome
Quality of life assessment using Rand SF36 standard survey
Time frame: Baseline, 6 and 12 months after sleep study
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
- Individual participant dataSharing planned: Yes
Related trials for Bronchiolitis Obliterans
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
Not yet recruiting
A New ECP Protocol for the Treatment of cGVHD
Chronic Graft Versus Host Disease
Active, not recruitingPhase 1/2
Alvelestat (MPH966), an Oral Neutrophil Elastase Inhibitor, in Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation
Chronic Graft vs Host Disease, Chronic Graft-Versus-Host Disease
RecruitingPhase 1
Ex Vivo-Expanded Regulatory T Cells Plus Low-Dose Interleukin-2 for Steroid-Refractory Chronic GVHD
Graft Versus Host Disease (cGvHD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Fiene, BA Med,Surg. FRACP MD principal investigator
The Prince Charles Hospital
James Douglas, MBBS FRACP MD principal investigator
The Prince Charles Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assessment of sleep disorders and treatment if required in people with Bronchiolitis Obliterans and Sleep Disordered Breathing Central, run by The Prince Charles Hospital at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Measure Prevalence of sleep disorders in Bronchiolitis Obliterans 2&3 patients (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2020.