Actively Recruiting
Accuracy of the Sensory Test Using the Laryngopharyngeal Endoscopic Esthesiometer in Obstructive Sleep Apnea
Led by Fundación Neumologica Colombiana · Updated on 2026-01-08
117
Participants Needed
2
Research Sites
465 weeks
Total Duration
On this page
Sponsors
F
Fundación Neumologica Colombiana
Lead Sponsor
U
Universidad de la Sabana
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Accuracy of the Sensory Test Using the Laryngopharyngeal Endoscopic Esthesiometer in Obstructive Sleep Apnea
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older referred for baseline polysomnography for suspected OSA at a university hospital sleep laboratory.
You will not qualify if you...
- Use of anticoagulation medications.
- Bleeding disorders.
- Basal awake oxygen saturation below 88%.
- Decline to participate in the study.
- Glasgow coma scale less than 15.
- Baseline polysomnography invalid or done more than 15 days before sensory testing.
- More than 5% of total apnea events are central in origin.
- History of maxillofacial or pharyngeal surgery.
- Presence of laryngopharyngeal tract malignancies.
- Central nervous system surgery in the last three months or neurological sequelae.
- Traumatic brain injury in the last three months or neurological sequelae.
- Active neuromuscular disease affecting head and neck muscles.
- History of cerebrovascular disease.
- Diabetes.
- Chronic use of systemic corticosteroids at doses ≥ 20 mg prednisone daily.
- Upper respiratory tract infection within 15 days prior to testing.
- Inability to cooperate during examination.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Fundacion Neumologica Colombiana
Bogotá, Bogota D.C., Colombia, 110131399
Actively Recruiting
2
Universidad de la Sabana
Chía, Cundinamarca, Colombia, 250001
Not Yet Recruiting
Research Team
L
Luis F Giraldo-Cadavid, MD, PhD
CONTACT
M
Maria A Bazurto, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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