Efficacy of Different Treatments for Obstructive Sleep Apnea

Not Applicable

Completed

• Conditions: Apnea
• Interventions: Device: Conventional mandibular advancement device; Device: CAD CAM mandibular advancement device

• Registration Number: NCT06352658
• Lead Sponsor: Nourhan M.Aly

Brief Summary

This was a prospective randomized controlled clinical trial that aimed to evaluate the efficacy of three treatments for obstructive sleep Apnea OSA:

1. Conventionally constructed mandibular advancement device (MAD).

2. Digitally constructed mandibular advancement device (CAD CAM).

3. Uvulopalatopharyngeoplasty (UPPP).

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-01
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-10
• Study First Submitted: 2024-04-02
• Study First Submitted QC: 2024-04-02
• Study First Posted: 2024-04-08
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Adequate nasal air flow capacity as determined by qualified otolaryngologist
• Cases showing improvement in airway with mandibular advancement on Acoustic Pharyngometry (AP)
• Patients with the minimum component of dentition to support MDSA.
• Patients with the mandibular protrusive movement of more than 5 mm
• Body mass index (BMI) less than 30 kg/m2

Exclusion Criteria

• Severe nasal passage obstructions or allergies
• Obesity (BMI greater than 30 kg/m2 )
• Cases with Mallampati score greater than Class 1
• Systemic complications, syndrome, or disease affecting airway
• Severe periodontal disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional mandibular advancement device	Conventional mandibular advancement device	-
CAD CAM mandibular advancement device	CAD CAM mandibular advancement device	-

Primary Outcome Measures

Name	Time	Method
Apnea hypopnea index	4 months	The AHI measures an average number of apnea and hypopnea episodes that you experience per hour. According to the American Academy of Sleep Medicine (AASM) it is categorized into mild (5-15 events/hour), moderate (15-30 events/hr), and severe (\> 30 events/hr)
Epwoth sleeplness scale (ESS)	4 months	The ESS is a subjective measure of a patient's sleepiness. The test is a list of eight situations in which the patien rates their tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing. All scores on the ESS fall between 0 and 24. Scores from 0 to 10 reflect normal levels of daytime sleepiness, and scores over 10 are considered to reflect excessive daytime sleepiness.
Oxygen saturation	4 months	This will be measured using an oximeter. A normal level of oxygen is usually 95% or higher.
Snoring index	4 months	Snoring index measures the total number of snores per hour of sleep. This is calculated by dividing your total sleeping time by your snoring frequency. The normal range depends on the person's gender and the stage of sleep

Trial Locations

Locations (1)

Faculty of Dentistry, Alexandria University, Egypt; 🇪🇬 Alexandria, Egypt