New throat test may spot sleep apnea faster
NCT ID NCT03109171
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing a new device that measures how sensitive the throat is to help diagnose obstructive sleep apnea (OSA). Researchers will compare the results of this test with standard sleep studies in 117 adults. The goal is to see if this simpler, quicker test can accurately identify people with OSA and determine how severe it is.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 117 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2018
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients being 18 years old or more referred to the sleep laboratory of a tertiary care university hospital for a baseline polysomnography for suspected OSA. Exclusion Criteria: * Anticoagulation (though not a contraindication for the endoscopic laryngopharyngeal sensory test, anticoagulation is an exclusion criteria for this validation study in order to keep it a minimal-risk study). * Bleeding diathesis. * Basal awake oxygen saturation by pulse oximetry below 88%. * Not agree to participate in the study. * Glasgow coma scale below of 15 (to avoid confusion with involvement of laryngopharyngeal reflexes due to neurological disease accompanied by decreased level of consciousness). * Baseline polysomnography that does not meet validity criteria to be interpreted (according to the American Academy of Sleep Medicine). * Baseline polysomnography performed more than 15 days before the sensory testing. Ordinarily, the sensory testing will be performed the same day or the next day of baseline polysomnography. * More than 5% of total apnoea events being of central origin. * History of maxillofacial or pharyngeal surgery (to avoid confusion with involvement of laryngopharyngeal reflexes due to surgery in this region). * Laryngopharyngeal tract malignancies (to avoid confusion with involvement of laryngopharyngeal reflexes due to tumours). * Central Nervous System (CNS) surgery in the last three months or that has left neurological sequelae (to avoid confusion with involvement of laryngopharyngeal reflexes due to sequelae of CNS surgery). * Traumatic brain injury in the last three months or more than three month with neurological sequelae. * History of active neuromuscular disease that affects the muscles of head and neck or with sequels present at the time of the sensory testing (to avoid confusion with involvement of laryngopharyngeal reflexes due to neuromuscular disease). * History of cerebrovascular disease (to avoid confusion with dysphagia or sensory compromise secondary to cerebrovascular disease). * Diabetes (to avoid confusion with diabetic neuropathy that compromises the laryngopharyngeal region). * Chronic use of systemic corticosteroids at a dose greater or equal to 20 mg per day of prednisone or equivalent (to avoid confusion with steroid myopathy that compromises the laryngopharyngeal region). * Upper respiratory tract infection within 15 days prior to the testing (to avoid confusion with neuropathy associated with respiratory viral disease that compromises the laryngopharyngeal region). * Patient's inability to cooperate during the examination (to avoid measurement error caused by the lack of cooperation of the patient).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fundacion Neumologica Colombiana
RECRUITINGBogotá, Bogota D.C., 110131399, Colombia
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Universidad de la Sabana
NOT_YET_RECRUITINGChía, Cundinamarca, 250001, Colombia
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Other studies related to the condition(s) this trial covers.
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- Can a new pressure relief mode outperform standard therapy for sleep apnea?
- Freezing away sleep apnea: a new procedure targets throat fat to open the airway
- Your smartwatch could spot sleep apnea: study tests At-Home screening
- Camera during sleep may reveal best surgery for apnea