Accuracy of the Sensory Test Using the Laryngopharyngeal Endoscopic Esthesiometer in Obstructive Sleep Apnea

NCT03109171 | Recruiting

• 1 other identifier: 201611-22405
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 2

Brief Summary

This is a prospective double blinded randomized crossover controlled trial aiming at validating the measurement of laryngopharyngeal mechanosensitivity in patients with suspected OSA using a recently developed laryngopharyngeal endoscopic esthesiometer and rangefinder (LPEER). Subjects will be recruited from patients with suspected OSA referred for baseline polysomnography to a university hospital sleep laboratory. Intra- and inter-rater reliability will be evaluated using the Bland-Altman's limits of agreement plot, the intraclass correlation coefficient, and the Pearson or Spearman correlation coefficient, depending on the distribution of the variables. Diagnostic accuracy will be evaluate plotting Receiver-operating-characteristic-curves (ROC-curves) using as reference standard basal polysomnogram. The sensory threshold values for patients with mild, moderate, and severe OSA, will be determined and compared using ANOVA or Kruskal Wallis test, depending on the distribution of the variables.

Conditions

Sleep Apnea, Obstructive; Larynx; Sensory Disorder

Keywords

Endoscopy; Lasers; Fiber Optic Technology; Bronchoscopy; Esthesiometer; Mechanoreceptors; Diagnosis; Reflex; Reproducibility of Results; Reliability of Results; Validity of Results; Sensory Thresholds

Outcome Measures

Primary Outcomes (3)

• Velopharynx psychophysical sensory threshold

  Sensitivity threshold at the velopharynx in millinewtons (mN).

  15 days

• Hypopharynx psychophysical sensory threshold

  Sensitivity threshold at the hypopharynx in millinewtons (mN).

  15 days

• Aryepiglottic fold psychophysical sensory threshold

  Sensitivity threshold at the aryepiglottic folds in millinewtons (mN).

  15 days

Secondary Outcomes (4)

• Apnea Hypopnea Index

  15 days

• Oxygen desaturation index

  15 days

• T90

  15 days

• Adverse Events

  15 days

Study Arms (2)

Expert rater

OTHER

Pulmonologist or Otolaryngologist with experience in laryngopharyngeal sensory evaluation: who has made more than 50 laryngopharyngeal sensory tests.

Other: Laryngopharyngeal sensory test

Non-expert rater

OTHER

* Pulmonologist or Otolaryngologist inexperienced in laryngopharyngeal sensory evaluation: who has made minimum 5 and maximum 50 laryngopharyngeal sensory tests. * Pulmonologist fellow who has completed the training provided for a Pulmonologist Fellow in bronchoscopy and who has performed minimum 5 and maximum 50 laryngopharyngeal sensory testing.

Other: Laryngopharyngeal sensory test

Interventions

Laryngopharyngeal sensory test OTHER

The sensory measurements will include thresholds for psychophysical sensory thresholds at the velopharynx, hypopharynx and aryepiglottic folds

Expert rater; Non-expert rater

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fundación Neumologica Colombiana: lead
• Universidad de la Sabana: collaborator
• Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS): collaborator

Study Sites (2)

Fundacion Neumologica Colombiana

Bogotá, Bogota D.C., 110131399, Colombia

RECRUITING

Universidad de la Sabana

Chía, Cundinamarca, 250001, Colombia

NOT YET RECRUITING

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Related Links

• Endoscopic Laryngopharyngeal Sensory Test (ELST) Protocol for the Validation of a Laryngo-Pharyngeal Endoscopic Esthesiometer and Rangefinder (LPEER)

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Laryngeal Diseases; Sensation Disorders; Disease

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Luis F Giraldo-Cadavid, MD, PhD

  University of La Sabana; Fundacion Neumologica Colombiana

  STUDY CHAIR

Central Study Contacts

Luis F Giraldo-Cadavid, MD, PhD

CONTACT

+573106083557; luisf.giraldo@unisabana.edu.co

Maria A Bazurto, MD

CONTACT

+577428900; mbazurto@neumologica.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The allocation sequence, determining which rater (expert vs non-expert) intervenes first or second, will be concealed using the SNOSE strategy (sequentially numbered opaque sealed envelopes). One of the authors (ARB), who has not competing interests will generate the allocation sequence and conceal it in envelopes. While the first rater measures the sensory thresholds (ST) the second rater will be at a different room for blinding purposes. There will be no communication about the testing results between the two raters nor the staff who are helping the testing performance. To mask the values of the ST, air pulses will be identified by a random combination of three letters instead of by the intensity levels corresponding to the air pulses. The raters will not know the intensity corresponding to each letter combination. At the end of the test, an assistant will replace the letters corresponding to the ST values by the intensity levels of the air pulses in units of force (millinewtons)
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pulmonologist

Model Details: Subjects participating in the inter-rater reliability evaluation will be evaluated by two raters, an expert and a non-expert rater, each rater performing two measurements of laryngopharyngeal sensory thresholds (ST) two times at each side (right and left) of the corresponding laryngopharyngeal structure. All other subjects, participating in the accuracy evaluation, will be evaluated by only one expert rater who will perform three measurements of laryngopharyngeal ST per subject. The varying degrees of rater experience aims to reproduce common scenarios when a new technique (like the measurement of laryngopharyngeal mechanosensitivity) is introduced to clinical practice. The two raters will measure the ST sequentially and in a randomized cross-over design in each subject (the order in which each rater intervenes will be randomized) aiming that the sensory tests be started an equal number of times by an expert rater and non-expert rater.

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: April 12, 2017
• Study Start: January 1, 2018
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CO (2)