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Clinical Trial of a Rehabilitation Device Based on Electrostimulation for Obstructive Sleep Apnoea

NCT04607343 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2026-04-13

No results posted yet for this study

Summary

The aim of this study is to evaluate in a clinical trial a rehabilitation device for patients with obstructive sleep apnoea (OSA) based on oropharyngeal electrical stimulation, which strengthens the dilating muscles of the upper airway, improves mechanical laryngopharyngeal sensitivity and improves OSA. Furthermore, to perform experimental electrotherapy, nasoendoscopy, polygraphy and polysomnography tests with the device in order to calculate thresholds of functional and sensory intensities on the dilating muscles of the upper airway in patients with OSA. These tests also include the detection of signals that measure breathing events during sleep in patients with OSA in order to use them in the control mechanisms of the electrostimulation device. Assess the effects and safety of the device in a group of five healthy volunteers for preliminary results. Finally, to evaluate in a small group of patients with OSA the device capacity to stimulate the upper-airway dilating muscles and to reduce the Apnea-Hypopnea Index (AHI) and oxygen desaturation indices when the electrostimulation device is used over a medium-term period (eight weeks) with morning and evening therapy sessions.

Conditions

  • Obstructive Sleep Apnoea

Interventions

DEVICE

Rehabilitation device based on electrical stimulation

Experimental tests with transcutaneous electrical stimulation at different intensities and at the points of the submandibular region previously explored will be conducted first of all on the five healthy volunteer subjects. During these tests, the neuromuscular thresholds of the upper airway, the most effective points of electrostimulation and the tolerance of intervention will be determined. The determination of the functional threshold will be made by clinical evaluation of the subject during stimulation.

Sponsors & Collaborators

  • Universidad de la Sabana

    collaborator OTHER

  • Fundación Neumologica Colombiana

    lead OTHER

Principal Investigators

  • Luis F Giraldo, MD, PhD · Fundación Neumológica Colombiana

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2027-07-01
Completion
2027-07-01

Countries

  • Colombia

Study Locations

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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 NCT04607343 on ClinicalTrials.gov