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

October 23, 2020 updated by: Luis F. Giraldo-Cadavid, Fundación Neumologica Colombiana

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Anticipated)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Assigned Interventions
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of the apnoea-hypopnea index (AHI) during sleep
Time Frame: 2 months
A median reduction of 10 on the AHI is expected with the intervention.
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Desaturation index
Time Frame: 2 months
number of desaturations per hour during sleep.
2 months
sleep time spent under 90% oxygen saturation (T90)
Time Frame: 2 months
Percentage of sleep time spent under 90% oxygen saturation.
2 months
oxygen saturation by pulse oximetry (SpO2) nadir
Time Frame: 2 months
Lowest oxygen saturation by pulse oximetry.
2 months
Mean SpO2
Time Frame: 2 months
Mean oxygen saturation by pulse oximetry.
2 months
Number of patients who lower one or more categories in the severity of OSA
Time Frame: 2 months
Moving from severe to moderate, severe to mild or moderate to mild OSA or normalising the AHI
2 months
Number of patients who climb one or more categories in the severity of OSA
Time Frame: 2 months
Moving from mild to moderate, mild to severe or moderate to severe OSA
2 months
Improvement in the Sleep Apnoea Quality of Life Index (SAQLI)
Time Frame: 2 months
Improvement in the quality of life as measured by the SAQLI
2 months
Improvement in the Epworth Sleepiness Scale (ESS)
Time Frame: 2 months
Improvement in daytime sleepiness as measured by the ESS
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Study Director: Luis F Giraldo, MD, PhD, Fundacion Neumologica Colombiana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2021

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

November 1, 2021

Study Registration Dates

First Submitted

September 22, 2020

First Submitted That Met QC Criteria

October 23, 2020

First Posted (Actual)

October 29, 2020

Study Record Updates

Last Update Posted (Actual)

October 29, 2020

Last Update Submitted That Met QC Criteria

October 23, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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