Obstructive Sleep ApnoeaNCT04607343
Clinical Trial of a Rehabilitation Device Based on Electrostimulation for Obstructive Sleep Apnoea
A study testing Rehabilitation device based on electrical stimulation in people with Obstructive Sleep Apnoea, run by Fundación Neumologica Colombiana at 2 sites in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnoea
- What is being tested?
- Rehabilitation device based on electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesColombia
- Study dates
- 1 Jul 2026to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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%.
Show all 26Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Colombia2 sites
Fundacion Neumologica Colombiana
Bogotá, Bogota D.C., 11111
Universidad de La Sabana
Chía, Cundinamarca
About this study
Official title: 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.
Read the 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.
- Conditions
- Obstructive Sleep Apnoea
- Being tested
- Rehabilitation device based on electrical stimulation
- Keywords
- Rehabilitation device, Electrical stimulation, Genioglossus muscle, Laryngopharyngeal sensory test
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation device based on electrical stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Rehabilitation device based on electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of the apnoea-hypopnea index (AHI) during sleep
A median reduction of 10 on the AHI is expected with the intervention.
Measured: 2 months
Secondary outcomes (8)
Desaturation index
number of desaturations per hour during sleep.
Measured: 2 months
sleep time spent under 90% oxygen saturation (T90)
Percentage of sleep time spent under 90% oxygen saturation.
Measured: 2 months
oxygen saturation by pulse oximetry (SpO2) nadir
Lowest oxygen saturation by pulse oximetry.
Measured: 2 months
Mean SpO2
Mean oxygen saturation by pulse oximetry.
Measured: 2 months
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
Measured: 2 months
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
Measured: 2 months
Improvement in the Sleep Apnoea Quality of Life Index (SAQLI)
Improvement in the quality of life as measured by the SAQLI
Measured: 2 months
Improvement in the Epworth Sleepiness Scale (ESS)
Improvement in daytime sleepiness as measured by the ESS
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Why it stopped: Lack of resourses and regulatory agency approval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApnoeaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Neumologica Colombiana
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de la Sabana
- Responsible party
- Principal investigator, Luis F. Giraldo-Cadavid, Fundación Neumologica Colombiana
- Investigators
- Luis F Giraldo, MD, PhD, Study director, Fundación Neumológica Colombiana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04607343
- Sponsor's protocol ID
- 201803 23403
- Status last verified
- Apr 2026
- First submitted
- 22 Sep 2020
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The patients clinical data will be entered into an anonymized database hosted on RedCap platform
Publications
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.
PubMed 15684207Gallas 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.
PubMed 19856025Gillick 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.
PubMed 22613094Guilleminault 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.
PubMed 729676Howlett 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.
PubMed 25634620Kezirian 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.
PubMed 20116305Schulte 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.
PubMed 2890103Page 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.
PubMed 25813373
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of a Rehabilitation Device Based on Electrical Stimulation for Patients With Obstructive Sleep Apnoea (OSA): a Study Protocol
- ClinicalTrials.gov ID
- NCT04607343
- Acronym / sponsor ID
- 201803 23403
- Conditions
- Obstructive Sleep Apnoea
- Keywords
- Rehabilitation device, Electrical stimulation, Genioglossus muscle, Laryngopharyngeal sensory test
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Lack of resourses and regulatory agency approval
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Fundación Neumologica ColombianaUniversity, hospital or other
- Collaborators
- Universidad de la Sabana
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 29 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Assigned Interventions | Experimental | Device: Rehabilitation device based on electrical stimulationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (26 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rehabilitation device based on electrical stimulationExperimental 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. | Device | Assigned Interventions |
Primary outcome
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.
8 secondary outcomes
Desaturation index
Time frame: 2 months
sleep time spent under 90% oxygen saturation (T90)
Time frame: 2 months
oxygen saturation by pulse oximetry (SpO2) nadir
Time frame: 2 months
Mean SpO2
Time frame: 2 months
Number of patients who lower one or more categories in the severity of OSA
Time frame: 2 months
Number of patients who climb one or more categories in the severity of OSA
Time frame: 2 months
Improvement in the Sleep Apnoea Quality of Life Index (SAQLI)
Time frame: 2 months
Improvement in the Epworth Sleepiness Scale (ESS)
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Background: PubMed 15684207Caples 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.
- Background: PubMed 19856025Gallas 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.
- Background: PubMed 22613094Gillick 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.
- Background: PubMed 729676Guilleminault 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.
- Background: PubMed 25634620Howlett 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.
- Background: PubMed 20116305Kezirian 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.
- Background: PubMed 2890103Schulte 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.
- Background: PubMed 25813373Page 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.
- Individual participant dataSharing planned: No. The patients clinical data will be entered into an anonymized database hosted on RedCap platform
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis F Giraldo, MD, PhD study director
Fundación Neumológica Colombiana
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation device based on electrical stimulation in people with Obstructive Sleep Apnoea, run by Fundación Neumologica Colombiana at 2 sites in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of the apnoea-hypopnea index (AHI) during sleep (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04607343, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.