Obstructive Sleep Apnea Therapy by Stimulation of the Hypoglossal Nerve

NCT03844295 | Completed DMC

• 1 other identifier: 38RC18.030
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

stimulation; hypoglossal nerve; Upper-airway

Outcome Measures

Primary Outcomes (1)

• Short-term efficacy of a new treatment for OSA on systolic blood pressure variability during sleep

  Change in the difference between delta nocturnal systolic blood pressure (difference between maximum and minimal nocturnal systolic blood pressure ; nocturnal period is defined from 10 pm to 7am).

  one month treatment active versus non active treatment

Secondary Outcomes (16)

• Short-term efficacy of a new treatment for OSA on mean-24h, daytime and nighttime blood pressure

  one month treatment active versus non active treatment

• Clinical efficacy of this new treatment on OSA by Epworth sleepiness scale score

  one month treatment active versus non active treatment

• Clinical efficacy of this new treatment on Apnea-Hypopnea Index measured by polysomnography

  one month treatment active versus non active treatment

• Change in sympatho-vagal balance based on heart rate variability analysis

  one month treatment active versus non active treatment

• Self-reported changes in sleep and quality of life by SF-36 score

  one month treatment active versus non active treatment

Study Arms (2)

Activated Inspire® Upper Airway Stimulation System

EXPERIMENTAL

INSPIRE® device will be active a month

Device: Activated Inspire® Upper Airway Stimulation System

Inactivated Inspire® Upper Airway Stimulation System

PLACEBO COMPARATOR

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

Device: Inactivated Inspire® Upper Airway Stimulation System

Interventions

Activated Inspire® Upper Airway Stimulation System DEVICE

At first, INSPIRE® device will be active a month

Activated Inspire® Upper Airway Stimulation System

Inactivated Inspire® Upper Airway Stimulation System DEVICE

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

Inactivated Inspire® Upper Airway Stimulation System

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient aged 18 to 80 years old
• Patient with moderate to severe OSA based on an established diagnosis of OSA (15≤AHI\<65) by polysomnography or respiratory polygraphy not older thant three years.
• Patient with moderate to severe OSA naïve of treatment or with difficulty accepting or adhering to CPAP treatment.
• Willing and capable to have stimulation hardware permanently implanted, and to use the patient programmer to activate the stimulation
• Willing and capable to return for all follow-up visits and conduct sleep studies at home, including the evaluation procedures and filling out questionnaires
• Willing and capable of providing written informed consent.

You may not qualify if:

• Any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate
• Have any condition or procedure that has compromised neurological control of the upper airway
• Unable to operate the patient programmer
• Pregnant or plan to become pregnant, and breastfeeding women
• Require magnetic resonance imaging (MRI)
• Have an implantable device that may be susceptible to unintended interaction with the Inspire system.
• Body Mass Index (BMI) of \>32
• Central + mixed apneas \> 25% of the total apnea-hypopnea index (AHI)
• Neuromuscular disease
• Hypoglossal-nerve palsy
• Severe restrictive or obstructive pulmonary disease
• Moderate-to-severe pulmonary arterial hypertension
• Severe valvular heart disease
• New York Heart Association class III or IV heart failure
• Recent myocardial infarction or severe cardiac arrhythmias (within the past 6 months)

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Inspire Medical Systems, Inc.: collaborator

Study Sites (1)

UniversityHospitalGrenoble

Grenoble, 38043, France

Location

Related Publications (17)

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MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Renaud RT TAMISIER, PhD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Only patient will be blind. He doesn't know if INSPIRE therapy was activated or not
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Monocentric, prospective, controlled, patient single-blind study

Study Record Dates

• First Submitted: October 18, 2018
• First Posted: February 18, 2019
• Study Start: March 21, 2019
• Primary Completion: December 22, 2021
• Study Completion: October 10, 2023
• Last Updated: July 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)