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Effect of Upper Airway Stimulation in Patients With Obstructive Sleep Apnea

NCT ID: NCT03760328

Last Updated: 2023-11-27

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

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-16

Study Completion Date

2021-12-30

Brief Summary

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Upper Airway Stimulation is a new therapy, which is available for patients with obstructive sleep apnea, who are non-compliant to the standard treatment continuous positive airway pressure (CPAP) therapy. This study is a prospective, multi-center, double-blinded, randomized crossover study conducted under a common protocol. The study visits include baseline with an in-laboratory polysomnography (PSG) after six months of therapy usage, followed by visits and in-lab PSGs at 1 and 2-weeks where the Therapy stimulation will be changed at each, according to randomization. The objective of this randomized controlled crossover study is to assess treatment effect of Inspire UAS in patients at different time points with two different therapy settings. This study will provide additional clinical evidence of Inspire UAS for treatment of moderate to severe OSA using a randomized controlled crossover trial design.

Detailed Description

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Obstructive Sleep Apnea (OSA) is characterized by recurrent episodes of airflow obstruction in the upper airway that results in oxygen desaturations and arousal from sleep. The most common symptom of OSA is excessive daytime sleepiness. Recent studies have also shown clear association of OSA with the development of obesity, hypertension diabetes mellitus, and congestive heart failure. Approximately 13% men and 6% women have moderate to severe OSA (apnea hypopnea index, AHI ≥ 15) in the US.

The efficacy of therapies for OSA, and in particular, continuous positive airway pressure (CPAP) has been limited due to patient intolerance, poor patient selection, or limited response to the therapy.

The Inspire Upper Airway Stimulation (UAS) system is intended to prevent upper airway obstruction by stimulating the hypoglossal nerve synchronous with respiration \[7\].

The Inspire system is comprised of the following components:

* Inspire Upper Airway Stimulator (Implantable Pulse Generator (IPG))
* Inspire Stimulation Lead
* Inspire Sensing Lead
* External programmers used with the system are:

* Inspire Programmer (physician programmer)
* Inspire Patient Programmer (patient remote)

The Inspire system received CE Mark in 2010 (CE Certificate No. 562872) providing the regulatory authority to provide the device in a commercial setting. Furthermore, this study will be conducted within the CE marked intended use of the Inspire system and will not involve any additional stressful or invasive tests.

The objective of this randomized controlled crossover study is to assess treatment effect of Inspire UAS in patients at different time points with two different therapy settings. This study will provide additional clinical evidence of Inspire UAS for treatment of moderate to severe OSA using a randomized controlled crossover trial design.

Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This study is a prospective, multi-center, randomized, crossover study, conducted under a common protocol. Subjects will be enrolled after they have been implanted and using the Inspire therapy (Inspire II/IV, Inspire Medical Systems, Maple Grove, USA) for at least six months. Participants will be randomized to one of two groups: therapeutic stimulation or sham stimulation. During the second phase of the study therapy settings of the stimulation system will be adjusted to crossover.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Neither the subject nor the investigator or Outcomes Assessor (double-blinded) will know the outcome of the randomization until after the subject has fulfilled and completed all study requirements at the end of the visit 3.

Study Groups

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therapeutic stimulation

Therapeutic Stimulation: optimal therapy setting for home use

Group Type ACTIVE_COMPARATOR

Upper Airway Stimulation

Intervention Type DEVICE

hypoglossal nerve stimulation by using a breathing cycle depended stimulation system of the upper airway

sham stimulation

Sham Stimulation (Control Group): stimulation voltage programmed at 0.1 volts

Group Type SHAM_COMPARATOR

Upper Airway Stimulation

Intervention Type DEVICE

hypoglossal nerve stimulation by using a breathing cycle depended stimulation system of the upper airway

Interventions

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Upper Airway Stimulation

hypoglossal nerve stimulation by using a breathing cycle depended stimulation system of the upper airway

Intervention Type DEVICE

Other Intervention Names

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Inspire

Eligibility Criteria

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Inclusion Criteria

* Otherwise healthy subjects that are at least 18 years old and:

1. Have been implanted and using the Inspire Therapy for at least six months
2. Willing and capable to undergo three in-lab PSGs in a one-month timeframe
3. Willing and capable of having reduced Inspire stimulation for one week
4. Willing and capable of providing informed consent

Exclusion Criteria

* Subjects who meet any of the following criteria will be excluded from this clinical investigation:

1. Unwilling to complete three in-lab PSGs within a 1-month timeframe
2. Any other reason the investigator deems subject is unfit for participation in the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitätsmedizin Mannheim

OTHER

Sponsor Role collaborator

University of Luebeck

OTHER

Sponsor Role collaborator

Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clemens Heiser, M.D.

Role: PRINCIPAL_INVESTIGATOR

Klinikum rechts der Isar, Technical University of Munich

Locations

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Department of Ear Nose Throat

Munich, Bavaria, Germany

Site Status

Countries

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Germany

References

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Steffen A, Moritz FJ, Konig IR, Suurna MV, Bruggemann N. Electric field aspects in hypoglossal nerve stimulation for obstructive sleep apnea: A bilateral electrophysiological evaluation of unilateral electrode configuration changes. J Sleep Res. 2023 Feb;32(1):e13592. doi: 10.1111/jsr.13592. Epub 2022 May 21.

Reference Type DERIVED
PMID: 35596592 (View on PubMed)

Related Links

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http://www.schlaf-hno.de

Homepage for Department

Other Identifiers

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EFFECT

Identifier Type: -

Identifier Source: org_study_id