Transcutaneous Electrical Stimulation in Obstructive Sleep Apnea

Randomised Controlled Trial of Transcutaneous Electrical Stimulation in Obstructive Sleep Apnea

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04932486

Enrollment

Registered

2021-06-21

Start date

2021-05-26

Completion date

2023-04-13

Last updated

2023-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

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.

Interventions

DEVICETranscutaneous electrical stimulation

Transcutaneous electrical stimulation of the upper airway muscles

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Apnea-hypopnea index (AHI)	6 weeks	Change from baseline to 6 weeks in the apnea-hypopnea index (AHI)

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026