- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04607343
Clinical Trial of a Rehabilitation Device Based on Electrostimulation for Obstructive Sleep Apnoea
Clinical Trial of a Rehabilitation Device Based on Electrical Stimulation for Patients With Obstructive Sleep Apnoea (OSA): a Study Protocol
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Luis F Giraldo-Cadavid, MD, PhD
- Phone Number: +573106083557
- Email: lfgiraldo@neumologica.org; luisgc@unisabana.edu.co
Study Locations
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Bogotá, D.C
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Bogotá, Bogotá, D.C, Colombia, 11111
- Fundacion Neumologica Colombiana
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Contact:
- Luis F Giraldo, MD, PhD
- Phone Number: +573106083557
- Email: lfgiraldo@neumologica.org; luisgc@unisabana.edu.co
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Cundinamarca
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Chía, Cundinamarca, Colombia
- Universidad de La Sabana
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Contact:
- William D Moscoso-Barrera, PhD
- Email: william.moscoso@unisabana.edu.co
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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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.
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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
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A median reduction of 10 on the AHI is expected with the intervention.
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2 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Desaturation index
Time Frame: 2 months
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number of desaturations per hour during sleep.
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2 months
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sleep time spent under 90% oxygen saturation (T90)
Time Frame: 2 months
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Percentage of sleep time spent under 90% oxygen saturation.
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2 months
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oxygen saturation by pulse oximetry (SpO2) nadir
Time Frame: 2 months
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Lowest oxygen saturation by pulse oximetry.
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2 months
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Mean SpO2
Time Frame: 2 months
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Mean oxygen saturation by pulse oximetry.
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2 months
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Number of patients who lower one or more categories in the severity of OSA
Time Frame: 2 months
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Moving from severe to moderate, severe to mild or moderate to mild OSA or normalising the AHI
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2 months
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Number of patients who climb one or more categories in the severity of OSA
Time Frame: 2 months
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Moving from mild to moderate, mild to severe or moderate to severe OSA
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2 months
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Improvement in the Sleep Apnoea Quality of Life Index (SAQLI)
Time Frame: 2 months
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Improvement in the quality of life as measured by the SAQLI
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2 months
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Improvement in the Epworth Sleepiness Scale (ESS)
Time Frame: 2 months
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Improvement in daytime sleepiness as measured by the ESS
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2 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Luis F Giraldo, MD, PhD, Fundacion Neumologica Colombiana
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201803 23403
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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