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Could a whisper in your ear treat sleep apnea?
NCT ID NCT07714330
First seen Jul 20, 2026 · Last updated Jul 22, 2026 · Updated 2 times
Summary
This study tests an in-ear device called WhisperPT that plays soft audio cues when a person sleeps on their back, encouraging them to shift position. It is designed for people with positional obstructive sleep apnea, where breathing problems are worse when lying face-up. The trial measures whether the device reduces breathing pauses and time spent back-sleeping, and how comfortable it is to use.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an investigational in-ear positional therapy device called WhisperPT that monitors head position and delivers gentle audio cues to discourage back-sleeping
- What this could lead to
- If effective, this device could offer a comfortable, non-invasive way to manage positional sleep apnea without a mask or bulky equipment.
- What could go wrong
- This is a small early study with only 30 participants, so results may not apply to everyone. The device may be uncomfortable or fail to consistently reduce back-sleeping.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Diagnosing sleep study identified a significant positional component to their obstructive sleep apnea (OSA) diagnosis as measured by at least a 50% reduction in Apnea-Hypopnea Index (AHI) while sleeping non-supine compared to supine * Diagnosing sleep study included at least 40% of the night recorded in supine and at least 20% of the night in non-supine position * Have an overall AHI \> 10 (4% desaturation) * Diagnosing sleep study included a minimum of 5 hours total sleep time (TST) * Willing to abstain from use of any other treatments for sleep-disordered breathing beginning at least 3 days prior to at-home study testing and for the remaining duration of their study participation * Between ages 18-75 * Must be able to refrain from alcohol use during nights of at-home study testing * Speaks and reads English sufficiently to understand the study informed consent, study instructions, and study materials * Signs study-specific informed consent form Exclusion Criteria: -Active medical conditions that would prevent study participation as determined by the principal investigator, including: Inability to easily move from between back and side in both directions Inability to sleep in lateral or supine position due to injury or a medical condition OR inability to sleep in a non-elevated/ tilted bed * Requiring medications to sleep * Prior diagnosis of a significant other sleep disorder such as restless leg syndrome/periodic limb movement disorder, primary central sleep apnea, pronounced insomnia, parasomnias, central disorder of hypersomnolence, etc * An active ear infection OR an ear infection within the past month OR a history of \>3 ear infections per year * Unusual outer ear, including enlarged or extra small anatomy, that prevents device use * Significant hearing impairment or ear skin issues, including: Participants with cochlear implants or those who will be affected by small magnets in the ear * Suffering from tinnitus * BMI \>35 * Current use of any illegal drugs. * Currently pregnant or currently lactating * Current enrollment in a clinical study of any other unapproved investigational drug or device. * Inability or unwillingness to comply with the study requirements. * Any other condition or laboratory value that could, in the professional opinion of the investigator, potentially affect response or participation in this clinical study, or would pose an unacceptable risk to the participant.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Peninsula Sleep Center
RECRUITINGBurlingame, California, 94010, United States
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