NCT04932486

Brief Summary

The aim of this study is to assess the efficacy of transcutaneous electrical stimulation of the upper airway muscles in patients with obstructive sleep apnea.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

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

May 26, 2021

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 21, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2023

Completed
Last Updated

April 14, 2023

Status Verified

April 1, 2023

Enrollment Period

1.9 years

First QC Date

June 3, 2021

Last Update Submit

April 13, 2023

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • Apnea-hypopnea index (AHI)

    Change from baseline to 6 weeks in the apnea-hypopnea index (AHI)

    6 weeks

Study Arms (1)

Transcutaneous electrical stimulation

EXPERIMENTAL

Participants will be asked to use the stimulator for 6 weeks at home. The study objectives will be evaluated after 6 weeks post-activation of the device.

Device: Transcutaneous electrical stimulation

Interventions

Transcutaneous electrical stimulationDEVICE

Transcutaneous electrical stimulation of the upper airway muscles

Transcutaneous electrical stimulation

Eligibility Criteria

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

You may qualify if:

  • Obstructive apnea-hypopnea index \> 15 events/hour
  • Patients who do not tolerate or do not accept positive airway pressure therapy

You may not qualify if:

  • Body mass index \< 18.5 or \> 32 kg/m2
  • Unable or incapable of providing informed written consent
  • Unwilling or incapable of returning to all follow-up visits and sleep studies, including evaluation procedures and filling out questionnaires
  • Significant co-morbidities making the patient unable or inappropriate to participate in the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Respisom

Namur, 5000, Belgium

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • Jean-Benoit Martinot

    Respisom

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2021

First Posted

June 21, 2021

Study Start

May 26, 2021

Primary Completion

April 13, 2023

Study Completion

April 13, 2023

Last Updated

April 14, 2023

Record last verified: 2023-04

Locations

BE(1)