NCT06661629

Brief 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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2024

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 28, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

December 20, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 13, 2025

Completed
Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

11 months

First QC Date

October 16, 2024

Last Update Submit

January 5, 2026

Conditions

OSA - Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (2)

  • Upper Airway Collapsability Measures

    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

    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 Outcomes (1)

  • Difference in Voltage Requirements

    During DISE - During the 20 minutes during which the Drug Induced Sleep Endoscopy occurs

Study Arms (1)

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 \[0.1 5.0 V\].

Device: Nerve stimulation

Interventions

Nerve stimulationDEVICE

The intervention is testing the effect of unilateral versus bilateral hypoglossal nerve stimulation on upper airway collapsibility during drug-induced sleep endoscopy

Unilateral vs Bilateral HGNS

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pregnant women\*

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Raj C Dedhia, MD

    Penn Medicine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2024

First Posted

October 28, 2024

Study Start

December 20, 2024

Primary Completion

November 13, 2025

Study Completion

November 13, 2025

Last Updated

January 8, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF