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

NCT04607343 | Suspended

• 1 other identifier: 201803 23403
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Rehabilitation device; Electrical stimulation; Genioglossus muscle; Laryngopharyngeal sensory test

Outcome Measures

Primary Outcomes (1)

• Improvement of the apnoea-hypopnea index (AHI) during sleep

  A median reduction of 10 on the AHI is expected with the intervention.

  2 months

Secondary Outcomes (8)

• Desaturation index

  2 months

• sleep time spent under 90% oxygen saturation (T90)

  2 months

• oxygen saturation by pulse oximetry (SpO2) nadir

  2 months

• Mean SpO2

  2 months

• Number of patients who lower one or more categories in the severity of OSA

  2 months

Study Arms (1)

Assigned Interventions

EXPERIMENTAL

Patients will undergo a conventional flexible nasopharyngeal laryngoscopy in which the degree of obstruction and the laryngopharyngeal sensitivity during wakefulness will be determined. Electrostimulation will be applied at different submandibular points with increasing intensity until the contraction of the dilation muscles of the airway or until the patient cannot tolerate the electrostimulation. The presence of contraction of stimulated muscles will be determined by external and endoscopic inspection.

Device: Rehabilitation device based on electrical stimulation

Interventions

Rehabilitation device based on electrical stimulation DEVICE

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.

Assigned Interventions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years of age with confirmed OSA (four with mild OSA, four with moderate OSA and four with severe OSA) who sign their informed consent to participate in the study.

You may not qualify if:

• Pregnancy
• Basal polysomnography that does not meet validity criteria to be interpreted.
• Haemorrhagic diathesis (to avoid risk of severe epistaxis during nasal endoscopy).
• Glasgow scale less than 15 (to avoid confusion with sensory or motor laryngopharyngeal involvement due to neurological disease that compromises the state of consciousness).
• Basal oxygen saturation by awake pulse oximetry below 88%.
• Patients with more than 5% of the total apnoea events being of central origin. (to avoid including patients with central sleep apnoea in whom laryngopharyngeal electrostimulation would have no effect).
• Inflammatory or infectious lesions on the face or neck
• Skin hypersensitivity
• Anaesthetic areas, burns, bruises or recent wounds in the area of electrical stimulation
• Cardiac pacemakers or other telemetry-controlled devices,
• History of maxillofacial or pharyngeal surgery.
• Active cancer
• Tumours of the laryngopharyngeal tract.
• Significant mental and/or behavioural conditions or inability of the patient to cooperate during the examination/intervention.
• Epilepsy

Sponsors & Collaborators

• Fundación Neumologica Colombiana: lead
• Universidad de la Sabana: collaborator

Study Sites (2)

Fundacion Neumologica Colombiana

Bogotá, Bogota D.C., 11111, Colombia

Location

Universidad de La Sabana

Chía, Cundinamarca, Colombia

Location

Related Publications (8)

• Caples SM, Gami AS, Somers VK. Obstructive sleep apnea. Ann Intern Med. 2005 Feb 1;142(3):187-97. doi: 10.7326/0003-4819-142-3-200502010-00010. No abstract available.

  PMID: 15684207 BACKGROUND

• Gallas S, Marie JP, Leroi AM, Verin E. Sensory transcutaneous electrical stimulation improves post-stroke dysphagic patients. Dysphagia. 2010 Dec;25(4):291-7. doi: 10.1007/s00455-009-9259-3. Epub 2009 Oct 24.

  PMID: 19856025 BACKGROUND

• Gillick BT, Zirpel L. Neuroplasticity: an appreciation from synapse to system. Arch Phys Med Rehabil. 2012 Oct;93(10):1846-55. doi: 10.1016/j.apmr.2012.04.026. Epub 2012 May 18.

  PMID: 22613094 BACKGROUND

• Guilleminault C, Hill MW, Simmons FB, Dement WC. Obstructive sleep apnea: electromyographic and fiberoptic studies. Exp Neurol. 1978 Oct;62(1):48-67. doi: 10.1016/0014-4886(78)90040-7. No abstract available.

  PMID: 729676 BACKGROUND

• Howlett OA, Lannin NA, Ada L, McKinstry C. Functional electrical stimulation improves activity after stroke: a systematic review with meta-analysis. Arch Phys Med Rehabil. 2015 May;96(5):934-43. doi: 10.1016/j.apmr.2015.01.013. Epub 2015 Jan 26.

  PMID: 25634620 BACKGROUND

• Kezirian EJ, Boudewyns A, Eisele DW, Schwartz AR, Smith PL, Van de Heyning PH, De Backer WA. Electrical stimulation of the hypoglossal nerve in the treatment of obstructive sleep apnea. Sleep Med Rev. 2010 Oct;14(5):299-305. doi: 10.1016/j.smrv.2009.10.009. Epub 2010 Jan 29.

  PMID: 20116305 BACKGROUND

• Schulte W, Scholze H, Werries E. Specificity of a cysteine proteinase of Entamoeba histolytica towards the alpha 1-CB2 peptide of bovine collagen type I. Mol Biochem Parasitol. 1987 Aug;25(1):39-43. doi: 10.1016/0166-6851(87)90016-8.

  PMID: 2890103 BACKGROUND

• Page SJ, Cunningham DA, Plow E, Blazak B. It takes two: noninvasive brain stimulation combined with neurorehabilitation. Arch Phys Med Rehabil. 2015 Apr;96(4 Suppl):S89-93. doi: 10.1016/j.apmr.2014.09.019.

  PMID: 25813373 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Luis F Giraldo, MD, PhD

  Fundación Neumológica Colombiana

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD. Pulmonary Medicine, Interventional Pulmonology

Model Details: Electrostimulation begins with electrodes placed on the skin in the submental and submandibular triangles, making sure not to place electrodes on the carotid sinus. The goal of this stimulation will be topographical closeness of the genioglossus, geniohyoid, mylohyoid, platysma and digastric muscles.

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: October 29, 2020
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CO (2)