Accuracy of the Sensory Test Using the Laryngopharyngeal Endoscopic Esthesiometer in Obstructive Sleep Apnea (NCT03109171)
Accuracy of the Sensory Test Performed Using the Laryngopharyngeal Endoscopic Esthesiometer and Rangefinder in Patients With Suspected Obstructive Sleep Apnoea Hypopnea (OSA): a Prospective Double-blinded, Randomised, Pilot Study
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Fundacion Neumologica Colombiana — Bogotá, Bogota D.C.
Age range: 18 Years
🧪 Interventions in This Study
- Laryngopharyngeal sensory test (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (2 Sites)
- Fundacion Neumologica Colombiana — Bogotá, Bogota D.C.
- Universidad de la Sabana — Chía, Cundinamarca
📞 Contact the Study Coordinator
Phone: +573106083557
Email: luisf.giraldo@unisabana.edu.co
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Sleep Apnea, Obstructive
- Safety and Effectiveness of the Genio® bilAteral Stimulation for Treatment of Complete Concentric CollapsE and OSA. — Colorado Springs, Colorado
- Predicting Outcomes in Hypoglossal Nerve Stimulation Therapy With Stimulated Upper Airway Mechanics — Baltimore, Maryland
- Long-term Evaluation of a Nasopharyngeal Airway — Ann Arbor, Michigan
- The REPOSE (Reach for Equity in Pediatric Sleep Evaluation) Navigation Intervention — Charleston, South Carolina
- A Study of Eloralintide (LY3841136) in Participants With Obstructive Sleep Apnea and Obesity or Overweight — Cullman, Alabama
- The IPAD Cohort Study: Insomnia and Positive Airway Pressure Adherence in Children and Adolescents — Vancouver, British Columbia
Explore by condition: All Sleep Apnea, Obstructive clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.