NCT03756805

Brief Summary

Standard therapy in patients with obstructive sleep apnea (OSA) is continuous positive airway pressure (CPAP). 30% to 50% are not adherent to this therapy and need an alternative treatment. Hypoglossal nerve stimulation or selective upper airway stimulation has been developed since several years. The aim of this clinical trial is to compare both treatments with each other.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
227

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 6, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 28, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

1.5 years

First QC Date

November 27, 2018

Last Update Submit

March 24, 2020

Conditions

Obstructive Sleep Apnea

Keywords

obstructive sleep apneahypoglossal nerve stimulationupper airway stimulationsurgical treatment sleep apnea

Outcome Measures

Primary Outcomes (2)

  • AHI

    Apnea Hypopnea Index measured in events per hour

    reduction from baseline to 12 months

  • ODI

    Oxygen desaturation index measured in events per hour

    reduction from baseline to 12 months

Secondary Outcomes (3)

  • ESS

    improvement from baseline to 12 months

  • FOSQ

    improvement from baseline to 12 months

  • Usage

    usage hours per night at 12 months

Study Arms (2)

Group 1 (CPAP)

ACTIVE COMPARATOR

Patient, who are receiving a CPAP

Device: continuous positive airway pressure

Group 2 (UAS)

EXPERIMENTAL

Patient, who are receiving a device for upper airway stimulation

Device: upper airway stimulation

Interventions

upper airway stimulationDEVICE

One group of patients with UAS

Also known as: Inspire
Group 2 (UAS)
continuous positive airway pressureDEVICE

One group of patients with CPAP

Group 1 (CPAP)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All consecutive patients who either received UAS implantation (Inspire therapy) in our Department of Otorhinolaryngology, Head and Neck Surgery at the Klinikum rechts der Isar and all patients who received a CPAP therapy since July 2013, are invited to participate in this clinical examination.

You may not qualify if:

  • patients with the age under 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Technical University of Munich

Munich, Bavaria, 81667, Germany

Location

Related Publications (1)

  • Heiser C, Steffen A, Strollo PJ Jr, Giaie-Miniet C, Vanderveken OM, Hofauer B. Hypoglossal nerve stimulation versus positive airway pressure therapy for obstructive sleep apnea. Sleep Breath. 2023 May;27(2):693-701. doi: 10.1007/s11325-022-02663-6. Epub 2022 Jul 2.

    PMID: 35779166DERIVED

Related Links

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients with moderate to severe sleep apnea (apnea-hypopnea index (AHI) between 15 / h and 65 / h) are included in the period 2014-2018. The patients are assigned to two groups: group 1, who are receiving PAP therapy and group 2, who are receiving upper airway stimulation. All patients receive polysomnography (PSG) in the sleep laboratory prior to therapy and are followed up on average 12 months after initiation of therapy by PSG or a home sleep test. This protocol is close to the daily clinical routine.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2018

First Posted

November 28, 2018

Study Start

July 6, 2018

Primary Completion

December 30, 2019

Study Completion

December 31, 2019

Last Updated

March 25, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)