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Obstructive Sleep Apnea Therapy by Stimulation of the Hypoglossal Nerve

NCT03844295 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2024-07-26

No results posted yet for this study

Summary

Continuous positive airway pressure (CPAP) is the gold standard to normalize breathing during sleep in patients with obstructive sleep apnea syndrom (OSA). Many patients will not tolerate or will not accept CPAP. Implanted nerve stimulation is a novel therapy for OSA patients that restores the upper airway potency using unilateral XII nerve electric stimulation.

The principal objective of this study is short-term efficacy of a new treatment for OSA on blood pressure variability during sleep.

Conditions

  • Obstructive Sleep Apnea Syndrome

Interventions

DEVICE

Activated Inspire® Upper Airway Stimulation System

At first, INSPIRE® device will be active a month

DEVICE

Inactivated Inspire® Upper Airway Stimulation System

After 15 days "wash-out" INSPIRE® device will be inactivated for a second period of one month.

Sponsors & Collaborators

  • Inspire Medical Systems, Inc.

    collaborator INDUSTRY

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Renaud RT TAMISIER, PhD · University Hospital, Grenoble

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-21
Primary Completion
2021-12-22
Completion
2023-10-10

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03844295 on ClinicalTrials.gov