Characterizing Bilateral Hypoglossal Nerve Stimulation During Drug-Induced Sleep Endoscopy (BLISS)

January 5, 2026 updated by: University of Pennsylvania

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults (≥ 22yrs) willing and capable of providing informed consent
  • Implanted with the Inspire hypoglossal nerve stimulator

Exclusion Criteria:

  • • Pregnant women*

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Unilateral vs Bilateral HGNS
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].
Device: Nerve stimulation
The intervention is testing the effect of unilateral versus bilateral hypoglossal nerve stimulation on upper airway collapsibility during drug-induced sleep endoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During DISE - during the 20 minutes that the Drug Induced Sleep Endoscopy Occurs.
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
During DISE - during the 20 minutes that the Drug Induced Sleep Endoscopy Occurs

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in Voltage Requirements
Time Frame: During DISE - During the 20 minutes during which the Drug Induced Sleep Endoscopy occurs
Difference in voltage between Inspire Device and External Stimulator during unilateral and bilateral stimulation
During DISE - During the 20 minutes during which the Drug Induced Sleep Endoscopy occurs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Investigators

  • Principal Investigator: Raj C Dedhia, MD, Penn Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 20, 2024

Primary Completion (Actual)

November 13, 2025

Study Completion (Actual)

November 13, 2025

Study Registration Dates

First Submitted

October 16, 2024

First Submitted That Met QC Criteria

October 24, 2024

First Posted (Actual)

October 28, 2024

Study Record Updates

Last Update Posted (Actual)

January 8, 2026

Last Update Submitted That Met QC Criteria

January 5, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25477

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

CTA is being drafted for data sharing between Penn Medicine and Inspire Medical Systems - IPD would be shared between Penn and Inspire.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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