Characterizing Bilateral Hypoglossal Nerve Stimulation During Drug-Induced Sleep Endoscopy

NCT ID: NCT06661629

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-20

Study Completion Date

2025-11-13

Brief Summary

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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.

Detailed Description

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Conditions

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OSA - Obstructive Sleep Apnea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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 \[0.1 5.0 V\].

Group Type EXPERIMENTAL

Nerve stimulation

Intervention Type DEVICE

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

Interventions

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Nerve stimulation

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* • Pregnant women\*
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raj C Dedhia, MD

Role: PRINCIPAL_INVESTIGATOR

Penn Medicine

Other Identifiers

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25477

Identifier Type: -

Identifier Source: org_study_id

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