OSA - Obstructive Sleep ApneaBLISSNCT06661629
Characterizing Bilateral Hypoglossal Nerve Stimulation During Drug-Induced Sleep Endoscopy
A study testing Nerve stimulation in people with OSA - Obstructive Sleep Apnea, run by University of Pennsylvania.
Trial summary
The study will investigate the treatment effect of bilateral genioglossus muscle stimulation on upper airway collapsibility during drug-induced sleep endoscopy in patients implanted with the Inspire hypoglossal nerve stimulator. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- OSA - Obstructive Sleep Apnea
- What is being tested?
- Nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2024to 13 Nov 2025
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥ 22yrs) willing and capable of providing informed consent
- Implanted with the Inspire hypoglossal nerve stimulator
Who cannot join
- • Pregnant women*
About this study
Official title: Characterizing Bilateral Hypoglossal Nerve Stimulation During Drug-Induced Sleep Endoscopy (BLISS - BiLateral Inspire Sedated Stimulation)
The study will investigate the treatment effect of bilateral genioglossus muscle stimulation on upper airway collapsibility during drug-induced sleep endoscopy in patients implanted with the Inspire hypoglossal nerve stimulator.
- Conditions
- OSA - Obstructive Sleep Apnea
- Being tested
- Nerve stimulation
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve stimulationDevice
The intervention is testing the effect of unilateral versus bilateral hypoglossal nerve stimulation on upper airway collapsibility during drug-induced sleep endoscopy
| Study group | Role | What they receive |
|---|---|---|
| Unilateral vs Bilateral HGNS | Experimental | All participants will undergo both unilateral and bilateral hypoglossal nerve stimulation during a single drug-induced sleep endoscopy exam. The voltage will be adjusted [0.1 5.0 V]. Receives: Device: Nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper Airway Collapsability Measures
PhOP - Pharangeal Opening Pressure, the minimum CPAP level needed to have an unobstructed airway
Measured: During DISE - during the 20 minutes that the Drug Induced Sleep Endoscopy Occurs.
Upper Airway Collapsability Measures
Pcrit - Critical Pressure, the maximum CPAP level where the airway is obstructed
Measured: During DISE - during the 20 minutes that the Drug Induced Sleep Endoscopy Occurs
Secondary outcomes (1)
Difference in Voltage Requirements
Difference in voltage between Inspire Device and External Stimulator during unilateral and bilateral stimulation
Measured: During DISE - During the 20 minutes during which the Drug Induced Sleep Endoscopy occurs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start20 Dec 2024 (estimated)
- Primary completion13 Nov 2025
- Study completion13 Nov 2025
Why it stopped: Study terminated prior to enrollment following mutual agreement between the sponsor and the site. No patients were recruited. No data was collected.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OSA - Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raj C Dedhia, MD, Principal investigator, Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06661629
- Sponsor's protocol ID
- 25477
- Acronym
- BLISS
- Status last verified
- Jan 2026
- First submitted
- 16 Oct 2024
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: CTA is being drafted for data sharing between Penn Medicine and Inspire Medical Systems - IPD would be shared between Penn and Inspire.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Bilateral Hypoglossal Nerve Stimulation During Drug-Induced Sleep Endoscopy (BLISS - BiLateral Inspire Sedated Stimulation)
- ClinicalTrials.gov ID
- NCT06661629
- Acronym / sponsor ID
- BLISS / 25477
- Conditions
- OSA - Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study terminated prior to enrollment following mutual agreement between the sponsor and the site. No patients were recruited. No data was collected.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 20 Dec 2024 (estimated)
- Primary completion
- 13 Nov 2025 (actual)
- Study completion
- 13 Nov 2025 (actual)
- First posted
- 28 Oct 2024 (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 study will investigate the treatment effect of bilateral genioglossus muscle stimulation on upper airway collapsibility during drug-induced sleep endoscopy in patients implanted with the Inspire hypoglossal nerve stimulator.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unilateral vs Bilateral HGNS | Experimental | Device: Nerve stimulationAll participants will undergo both unilateral and bilateral hypoglossal nerve stimulation during a single drug-induced sleep endoscopy exam. The voltage will be adjusted [0.1 5.0 V]. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults (≥ 22yrs) willing and capable of providing informed consent
- Implanted with the Inspire hypoglossal nerve stimulator
Key exclusion criteria (1 listed)
- • Pregnant women*
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 |
|---|---|---|
| Nerve stimulationThe intervention is testing the effect of unilateral versus bilateral hypoglossal nerve stimulation on upper airway collapsibility during drug-induced sleep endoscopy | Device | Unilateral vs Bilateral HGNS |
Primary outcome
Upper Airway Collapsability Measures
Time frame: During DISE - during the 20 minutes that the Drug Induced Sleep Endoscopy Occurs.
PhOP - Pharangeal Opening Pressure, the minimum CPAP level needed to have an unobstructed airway
Upper Airway Collapsability Measures
Time frame: During DISE - during the 20 minutes that the Drug Induced Sleep Endoscopy Occurs
Pcrit - Critical Pressure, the maximum CPAP level where the airway is obstructed
1 secondary outcome
Difference in Voltage Requirements
Time frame: During DISE - During the 20 minutes during which the Drug Induced Sleep Endoscopy occurs
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 8 Jan 2026.
- Individual participant dataSharing planned: Yes. CTA is being drafted for data sharing between Penn Medicine and Inspire Medical Systems - IPD would be shared between Penn and Inspire.
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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.
Raj C Dedhia, MD principal investigator
Penn Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Nerve stimulation in people with OSA - Obstructive Sleep Apnea, run by University of Pennsylvania.
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 2 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: withdrawn, as of the sponsor's last update on 8 Jan 2026. 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. 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?
Upper Airway Collapsability Measures (time frame: During DISE - during the 20 minutes that the Drug Induced Sleep Endoscopy Occurs.). The study lists 2 primary outcomes in all. 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 8 Jan 2026; AzTrials last refreshed its copy on 6 Nov 2026.