Back to results

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

Primary Purpose

Obstructive Sleep Apnoea

Status

Unknown status

Phase

Not Applicable

Locations

Colombia

Study Type

Interventional

Intervention

Rehabilitation device based on electrical stimulation

About this trial

This is an interventional other trial for Obstructive Sleep Apnoea focused on measuring Rehabilitation device, Electrical stimulation, Genioglossus muscle, Laryngopharyngeal sensory test

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

Pregnancy
Basal polysomnography that does not meet validity criteria to be interpreted.
Anticoagulation (although not a contraindication for laryngopharyngeal sensory endoscopic testing, anticoagulation is an exclusion criterion for this study to maintain the lowest level of risk).
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
Central Nervous System (CNS) surgery in the last three months (to avoid confusion with muscle or sensory laryngopharyngeal compromise).
Brain trauma in the last three months (to avoid confusion with muscle or sensory laryngopharyngeal compromise).
Neurological sequelae of any cause compromising the head and neck muscles (to avoid confusion with muscle or sensory laryngopharyngeal compromise).
Underlying neuromuscular diseases affecting the head and neck muscles (to avoid confusion with muscle or sensory laryngopharyngeal involvement due to neuromuscular disease).
Chronic use of systemic corticosteroids at doses greater than or equal to 20 mg daily of prednisone or equivalent (to avoid confusion with corticosteroid myopathy that compromises the laryngopharyngeal region).
Bone prostheses or osteosynthesis (in polarized currents there is danger of chemical burn and bone resorption)
Acute febrile processes
Chronic decompensated diseases
Diseases in terminal states
Refusal to participate in the study.

Sites / Locations

Fundacion Neumologica Colombiana
Universidad de La Sabana

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Assigned Interventions

Arm Description

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.

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Desaturation index

number of desaturations per hour during sleep.

sleep time spent under 90% oxygen saturation (T90)

Percentage of sleep time spent under 90% oxygen saturation.

oxygen saturation by pulse oximetry (SpO2) nadir

Lowest oxygen saturation by pulse oximetry.

Mean SpO2

Mean oxygen saturation by pulse oximetry.

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

Moving from severe to moderate, severe to mild or moderate to mild OSA or normalising the AHI

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

Moving from mild to moderate, mild to severe or moderate to severe OSA

Improvement in the Sleep Apnoea Quality of Life Index (SAQLI)

Improvement in the quality of life as measured by the SAQLI

Improvement in the Epworth Sleepiness Scale (ESS)

Improvement in daytime sleepiness as measured by the ESS

Full Information

NCT ID

NCT04607343

First Posted

September 22, 2020

Last Updated

October 23, 2020

Sponsor

Fundación Neumologica Colombiana

Collaborators

Universidad de la Sabana

1. Study Identification

Unique Protocol Identification Number

NCT04607343

Brief Title

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

Official Title

Clinical Trial of a Rehabilitation Device Based on Electrical Stimulation for Patients With Obstructive Sleep Apnoea (OSA): a Study Protocol

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Unknown status

Study Start Date

January 2021 (Anticipated)

Primary Completion Date

June 2021 (Anticipated)

Study Completion Date

November 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fundación Neumologica Colombiana

Collaborators

Universidad de la Sabana

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Obstructive sleep apnoea-hypopnoea syndrome (OSA) is a respiratory disorder characterised by repetitive obstruction of the upper airway, leading to several interruptions during sleep. It is currently one of the main public health problems worldwide and one of the main cardiovascular risk factors in developed and intermediate developing countries, whose populations are increasing in obesity and age. One of the common treatments for OSA is continuous positive airway pressure (CPAP) devices, which pumps air through a hose, reaches a mask that the patient has over his or her nose and travels the airway, keeping the upper airway open during sleep and avoiding episodes of airway collapse. The problem is that CPAP is not accepted by some patients due to a lack of adaptation, so alternative treatments may be needed. For some years, there have been explorations of treatments related to electrical stimulation of the muscles of the upper airway as therapy to reduce the number of episodes of apnoea (measured through the apnoea-hypopnoea index) during the night, strengthening these muscles through stimulation. This is the protocol of a clinical study of a rehabilitation device for home use that not only provides functional stimulation of the upper-airway dilator muscles but also provides sensory stimulation. This device works by strengthening the dilating muscles of the upper respiratory tract and improving the sensory capacity of the laryngo-pharyngeal tract and is based on existing publications on the effectiveness of functional and somatosensory neurostimulation through neuroplasticity in the recovery of neurological deficits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstructive Sleep Apnoea

Keywords

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

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

N/A

Enrollment

17 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Assigned Interventions

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Rehabilitation device based on electrical stimulation

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

2 months

Secondary Outcome Measure Information:

Title

Desaturation index

Description

number of desaturations per hour during sleep.

Time Frame

2 months

Title

sleep time spent under 90% oxygen saturation (T90)

Description

Percentage of sleep time spent under 90% oxygen saturation.

Time Frame

2 months

Title

oxygen saturation by pulse oximetry (SpO2) nadir

Description

Lowest oxygen saturation by pulse oximetry.

Time Frame

2 months

Title

Mean SpO2

Description

Mean oxygen saturation by pulse oximetry.

Time Frame

2 months

Title

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

Description

Moving from severe to moderate, severe to mild or moderate to mild OSA or normalising the AHI

Time Frame

2 months

Title

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

Description

Moving from mild to moderate, mild to severe or moderate to severe OSA

Time Frame

2 months

Title

Improvement in the Sleep Apnoea Quality of Life Index (SAQLI)

Description

Improvement in the quality of life as measured by the SAQLI

Time Frame

2 months

Title

Improvement in the Epworth Sleepiness Scale (ESS)

Description

Improvement in daytime sleepiness as measured by the ESS

Time Frame

2 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: Pregnancy Basal polysomnography that does not meet validity criteria to be interpreted. Anticoagulation (although not a contraindication for laryngopharyngeal sensory endoscopic testing, anticoagulation is an exclusion criterion for this study to maintain the lowest level of risk). 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 Central Nervous System (CNS) surgery in the last three months (to avoid confusion with muscle or sensory laryngopharyngeal compromise). Brain trauma in the last three months (to avoid confusion with muscle or sensory laryngopharyngeal compromise). Neurological sequelae of any cause compromising the head and neck muscles (to avoid confusion with muscle or sensory laryngopharyngeal compromise). Underlying neuromuscular diseases affecting the head and neck muscles (to avoid confusion with muscle or sensory laryngopharyngeal involvement due to neuromuscular disease). Chronic use of systemic corticosteroids at doses greater than or equal to 20 mg daily of prednisone or equivalent (to avoid confusion with corticosteroid myopathy that compromises the laryngopharyngeal region). Bone prostheses or osteosynthesis (in polarized currents there is danger of chemical burn and bone resorption) Acute febrile processes Chronic decompensated diseases Diseases in terminal states Refusal to participate in the study.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Luis F Giraldo-Cadavid, MD, PhD

Phone

+573106083557

lfgiraldo@neumologica.org; luisgc@unisabana.edu.co

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Luis F Giraldo, MD, PhD

Organizational Affiliation

Fundación Neumológica Colombiana

Official's Role

Study Director

Facility Information:

Facility Name

Fundacion Neumologica Colombiana

City

Bogotá

State/Province

Bogotá, D.C

ZIP/Postal Code

11111

Country

Colombia

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Luis F Giraldo, MD, PhD

Phone

+573106083557

lfgiraldo@neumologica.org; luisgc@unisabana.edu.co

Facility Name

Universidad de La Sabana

City

Chía

State/Province

Cundinamarca

Country

Colombia

Facility Contact:

First Name & Middle Initial & Last Name & Degree

William D Moscoso-Barrera, PhD

william.moscoso@unisabana.edu.co

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

The patients clinical data will be entered into an anonymized database hosted on RedCap platform

Citations:

PubMed Identifier

15684207

Citation

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.

Results Reference

background

PubMed Identifier

19856025

Citation

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.

Results Reference

background

PubMed Identifier

22613094

Citation

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.

Results Reference

background

PubMed Identifier

729676

Citation

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.

Results Reference

background

PubMed Identifier

25634620

Citation

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.

Results Reference

background

PubMed Identifier

20116305

Citation

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.

Results Reference

background

PubMed Identifier

2890103

Citation

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.

Results Reference

background

PubMed Identifier

25813373

Citation

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.

Results Reference

background

Learn more about this trial

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

We'll reach out to this number within 24 hrs