Effect of Upper Airway Stimulation in Patients With Obstructive Sleep Apnea

NCT03760328 | Completed DMC

• 1 other identifier: EFFECT
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (2)

• Change in AHI from Baseline to Visit 1 and Visit 2

  Apnea Hypopnea Index (AHI) is a measure of OSA severity. The AHI in this study will be determined by the AHI score at Visit 1 and Visit 2 compared with the baseline score.

  Baseline through Visit 1 (1 week) and Visit 2 (2 weeks)

• Change in ESS from Baseline to Visit 1 and Visit 2

  The Epworth Sleepiness Scale (ESS) is a validated instruction that rates a subject's daytime sleepiness. The ESS efficacy endpoint will be determined by the ESS score at Visit 1 and Visit 2 as compared to baseline.

  Baseline through Visit 1 (1 week) and Visit 2 (2 weeks)

Secondary Outcomes (5)

• Change in FOSQ from Baseline to Visit 1 and Visit 2

  Baseline through Visit 1 (1 week) and Visit 2 (2 weeks)

• Change in Snoring Intensity from Baseline to Visit 1 and Visit 2

  Baseline through Visit 1 (1 week) and Visit 2 (2 weeks)

• Therapy Adherence

  Baseline through Visit 1 (1 week) and Visit 2 (2 weeks)

• Change in ODI from Baseline to Visit 1 and Visit 2

  Baseline through Visit 1 (1 week) and Visit 2 (2 weeks)

• Change in Clinical Global Impression (CGI-I) from Baseline to Visit 1 and Visit 2

  Baseline through Visit 1 (1 week) and Visit 2 (2 weeks)

Study Arms (2)

therapeutic stimulation

ACTIVE COMPARATOR

Therapeutic Stimulation: optimal therapy setting for home use

Device: Upper Airway Stimulation

sham stimulation

SHAM COMPARATOR

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

Device: Upper Airway Stimulation

Interventions

Upper Airway Stimulation DEVICE

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

Also known as: Inspire

sham stimulation; therapeutic stimulation

Eligibility Criteria

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

You may qualify if:

• Otherwise healthy subjects that are at least 18 years old and:
• Have been implanted and using the Inspire Therapy for at least six months
• Willing and capable to undergo three in-lab PSGs in a one-month timeframe
• Willing and capable of having reduced Inspire stimulation for one week
• Willing and capable of providing informed consent

You may not qualify if:

• Subjects who meet any of the following criteria will be excluded from this clinical investigation:
• Unwilling to complete three in-lab PSGs within a 1-month timeframe
• Any other reason the investigator deems subject is unfit for participation in the study

Sponsors & Collaborators

• Technical University of Munich: lead
• Universitätsmedizin Mannheim: collaborator
• University of Luebeck: collaborator

Study Sites (1)

Department of Ear Nose Throat

Munich, Bavaria, 81675, Germany

Location

Related Publications (1)

• 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.

  PMID: 35596592 DERIVED

Related Links

• Homepage for Department

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

• Clemens Heiser, M.D.

  Klinikum rechts der Isar, Technical University of Munich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: November 30, 2018
• Study Start: January 16, 2019
• Primary Completion: May 31, 2020
• Study Completion: December 30, 2021
• Last Updated: November 27, 2023

Record last verified: 2020-10

Locations

DE (1)