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

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University of Pennsylvania

Status

Withdrawn

Conditions

OSA - Obstructive Sleep Apnea

Treatments

Device: Nerve stimulation

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • • Pregnant women*

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

Unilateral vs Bilateral HGNS
Experimental group
Description:
All participants will undergo both unilateral and bilateral hypoglossal nerve stimulation during a single drug-induced sleep endoscopy exam. The voltage will be adjusted \[0.1 5.0 V\].
Treatment:
Device: Nerve stimulation

Trial contacts and locations

0

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Central trial contact

Everett G Seay, BS, RPSGT

Data sourced from clinicaltrials.gov

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