Sleep ApneaNCT02159664
Influence of Didgeridoo Practice on UA Obstruction Levels in Moderate OSA
A study testing didgeridoo practice in people with Sleep Apnea, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
Trial summary
Didgeridoo practice has been shown to improve OSA severity. The aim of our study is to assess the changes in upper airways obstruction levels before and after Didgeridoo practice in moderate OSA patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- didgeridoo practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2014to Mar 2016
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- moderate OSA, non obese
Who cannot join
- not willing play didgeridoo age<18 significant lung, cardiac disease neuromuscular disease psychiatric disorders drugs with influence on respiratory drive
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Didgeridoo Practice on Upper Airways Obstruction Levels in Moderate Obstructive Sleep Apnea Patients
Didgeridoo practice has been shown to improve OSA severity. The aim of our study is to assess the changes in upper airways obstruction levels before and after Didgeridoo practice in moderate OSA patients.
Read the detailed description
Didgeridoo practice has been shown to improve Obstructive Sleep Apnea (OSA) severity. The aim of our study is to assess the changes in upper airways obstruction levels, evaluated by sleep endoscopy, before and after 3 months of Didgeridoo practice in moderate non obese OSA patients. Severity of OSA will also be documented by polysomnography.
- Conditions
- Sleep Apnea
- Being tested
- didgeridoo practice
- Keywords
- didgeridoo, sleep apnea, drug induced sleep endoscopy
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
didgeridoo practiceOther
instrument lessons, 1X/w and daily practice, 20 min /d
| Study group | Role | What they receive |
|---|---|---|
| didgeridoo practice | Experimental | Not described Receives: Other: didgeridoo practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
upper airways obstruction levels
assessed by drug-induced sleep endoscopy
Measured: 3 months
Secondary outcomes (1)
apnea-hypopnea index
assessed by polysomnography
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2014 (estimated)
- Study startDec 2014
- Primary completionMar 2016
- Study completionMar 2016
Why it stopped: difficulty to recrut patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Bruyneel, Centre Hospitalier Universitaire Saint Pierre
- Investigators
- Marie Bruyneel, MD, Principal investigator, CHU St Pierre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02159664
- Sponsor's protocol ID
- AK/14-03-25/4354
- Status last verified
- Sep 2017
- First submitted
- 6 Jun 2014
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Didgeridoo Practice on Upper Airways Obstruction Levels in Moderate Obstructive Sleep Apnea Patients
- ClinicalTrials.gov ID
- NCT02159664
- Acronym / sponsor ID
- AK/14-03-25/4354
- Conditions
- Sleep Apnea
- Keywords
- didgeridoo, sleep apnea, drug induced sleep endoscopy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulty to recrut patients
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 10 Jun 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.
Didgeridoo practice has been shown to improve OSA severity. The aim of our study is to assess the changes in upper airways obstruction levels before and after Didgeridoo practice in moderate OSA patients.
Detailed description
Didgeridoo practice has been shown to improve Obstructive Sleep Apnea (OSA) severity. The aim of our study is to assess the changes in upper airways obstruction levels, evaluated by sleep endoscopy, before and after 3 months of Didgeridoo practice in moderate non obese OSA patients. Severity of OSA will also be documented by polysomnography.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| didgeridoo practice | Experimental | Other: didgeridoo practice |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- moderate OSA, non obese
Key exclusion criteria (1 listed)
- not willing play didgeridoo age<18 significant lung, cardiac disease neuromuscular disease psychiatric disorders drugs with influence on respiratory drive
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 |
|---|---|---|
| didgeridoo practiceinstrument lessons, 1X/w and daily practice, 20 min /d | Other | didgeridoo practice |
Primary outcome
upper airways obstruction levels
Time frame: 3 months
assessed by drug-induced sleep endoscopy
1 secondary outcome
apnea-hypopnea index
Time frame: 3 months
Results and safety
The study was stopped early (reason given: difficulty to recrut patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2017.
Related trials for Sleep Apnea
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Recruiting
Janus II Feasibility
Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
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.
Marie Bruyneel, MD principal investigator
CHU St Pierre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing didgeridoo practice in people with Sleep Apnea, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 11 Sep 2017. 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 Belgium. 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 stopped early (reason given: difficulty to recrut patients). Results are not available in the source record.
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?
upper airways obstruction levels (time frame: 3 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 11 Sep 2017.