MedTrace Logo

Effect of Upper Airway Stimulation in Patients With Obstructive Sleep Apnea

NCT03760328 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-11-27

No results posted yet for this study

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

Interventions

DEVICE

Upper Airway Stimulation

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

Sponsors & Collaborators

  • Universitätsmedizin Mannheim

    collaborator OTHER

  • University of Luebeck

    collaborator OTHER

  • Technical University of Munich

    lead OTHER

Principal Investigators

  • Clemens Heiser, M.D. · Klinikum rechts der Isar, Technical University of Munich

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-16
Primary Completion
2020-05-31
Completion
2021-12-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

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 NCT03760328 on ClinicalTrials.gov