Sleep ApneaNCT04053153
Effects of Upper Airway Muscle Training on Obstructive Sleep Apnea Severity
A study testing Exercise equipment (a musical instrument that is based on the Medical Didgeridoo) in people with Sleep Apnea, run by Stanford University.
Trial summary
The purpose of this study is to evaluate the effect of Asate Silent Sleep Training on obstructive sleep apnea (OSA) severity in patients with mild to moderate OSA. The Asate Silent Sleep Training is a muscle strengthening program that uses exercise equipment (a musical instrument that is based on the didgeridoo). Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- Exercise equipment (a musical instrument that is based on the Medical Didgeridoo)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2021to 30 Sep 2021
- 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 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 21 to 50
- Diagnosed by a physician with mild to moderate OSA, based upon interpretation of data recorded on a take home sleep study
- Body mass index < 30 kg/m2
- Mild to moderate OSA, AHI of 5-30
Who cannot join
- Apnea hypopnea index on overnight sleep study > 30 per hour
- Currently practices didgeridoo
- Consumes more than 2 alcoholic beverages per day
- History of chronic lung disease (e.g., COPD, asthma)
- Oral maxillofacial issue or craniofacial musculoskeletal conditions
- Any treatment for OSA (current or past)
Show all 16Show fewer
- Mobile device use frequency < once per week
- Homelessness
- No reliable transportation to assessment sessions
- Planned social/family/employment obligations that would limit participant from engaging in Asate Silent Sleep training during the intervention period
- Significant upper extremity weakness/paralysis or pain limiting ability to hold the Medical Didgeridoo
- Uncorrected low vision or blindness
- Deafness
- No Internet connection/Chrome browser/mobile devices with iOS and Android
- No USB port in computer
- Pregnancy
About this study
The purpose of this study is to evaluate the effect of Asate Silent Sleep Training on obstructive sleep apnea (OSA) severity in patients with mild to moderate OSA. The Asate Silent Sleep Training is a muscle strengthening program that uses exercise equipment (a musical instrument that is based on the didgeridoo). The equipment is connected to an application, which provides instruction on how to perform the strengthening exercises, measures the sound produced by the musical instrument, which enables the app to provide feedback on whether the individual should blow less or more and also tracks adherence to the strengthening program.
- Conditions
- Sleep Apnea
- Being tested
- Exercise equipment (a musical instrument that is based on the Medical Didgeridoo)
- 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.
Exercise equipment (a musical instrument that is based on the Medical Didgeridoo)Device
exercise equipment (a musical instrument that is based on the Medical Didgeridoo)
| Study group | Role | What they receive |
|---|---|---|
| Use of musical instrument | Experimental | Not described Receives: Device: Exercise equipment (a musical instrument that is based on the Medical Didgeridoo) |
| Use of sham musical instrument | Sham comparator | Not described Receives: Device: Exercise equipment (a musical instrument that is based on the Medical Didgeridoo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea Hypopnea Index (AHI)
Apnea Hypopnea Index during sleep
Measured: 8-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2019
- Study start1 May 2021 (estimated)
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Why it stopped: Funding issues
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.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Asate LLC, DE
- Responsible party
- Principal investigator, Clete A. Kushida, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04053153
- Sponsor's protocol ID
- IRB-46406
- Status last verified
- May 2022
- First submitted
- 8 Aug 2019
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Upper Airway Muscle Training on Obstructive Sleep Apnea Severity
- ClinicalTrials.gov ID
- NCT04053153
- Acronym / sponsor ID
- IRB-46406
- Conditions
- Sleep Apnea
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Asate LLC, DE
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 12 Aug 2019 (actual)
- 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.
The purpose of this study is to evaluate the effect of Asate Silent Sleep Training on obstructive sleep apnea (OSA) severity in patients with mild to moderate OSA. The Asate Silent Sleep Training is a muscle strengthening program that uses exercise equipment (a musical instrument that is based on the didgeridoo). The equipment is connected to an application, which provides instruction on how to perform the strengthening exercises, measures the sound produced by the musical instrument, which enables the app to provide feedback on whether the individual should blow less or more and also tracks adherence to the strengthening program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Use of musical instrument | Experimental | Device: Exercise equipment (a musical instrument that is based on the Medical Didgeridoo) |
| Use of sham musical instrument | Sham comparator | Device: Exercise equipment (a musical instrument that is based on the Medical Didgeridoo) |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 21 to 50
- Diagnosed by a physician with mild to moderate OSA, based upon interpretation of data recorded on a take home sleep study
- Body mass index < 30 kg/m2
- Mild to moderate OSA, AHI of 5-30
Key exclusion criteria (16 listed)
- Apnea hypopnea index on overnight sleep study > 30 per hour
- Currently practices didgeridoo
- Consumes more than 2 alcoholic beverages per day
- History of chronic lung disease (e.g., COPD, asthma)
- Oral maxillofacial issue or craniofacial musculoskeletal conditions
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 |
|---|---|---|
| Exercise equipment (a musical instrument that is based on the Medical Didgeridoo)exercise equipment (a musical instrument that is based on the Medical Didgeridoo) | Device | Use of musical instrument, Use of sham musical instrument |
Primary outcome
Apnea Hypopnea Index (AHI)
Time frame: 8-12 weeks
Apnea Hypopnea Index during sleep
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 24 May 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise equipment (a musical instrument that is based on the Medical Didgeridoo) in people with Sleep Apnea, run by Stanford University.
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 4 inclusion and 16 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 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Apnea Hypopnea Index (AHI) (time frame: 8-12 weeks). 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 24 May 2022.