Efficacy of Different Treatments for Obstructive Sleep Apnea

Efficacy of Different Treatment Modalities for Obstructive Sleep Apnea: a Randomized Controlled Clinical Trial

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).

Study Overview

• Status: Completed
• Conditions: Apnea
• Intervention / Treatment: Device: Conventional mandibular advancement device; Device: CAD CAM mandibular advancement device; Procedure: Uvuloplatopharyngeoplasty UPPP

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Faculty of Dentistry, Alexandria University, Egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional mandibular advancement device	Device: Conventional mandibular advancement device; With a vacuum mahine (Biostar, NY) a 2-mm-thick hard, clear resin sheet was adapted to the cast. The excess material was cut, borders were trimmed and smoothed. Maxillary mandibular casts were mounted by a protrusive the interocclusal record. The appliances were re-placed on the mounted casts to be splinted to form a Monoblock MAD by autopolymerizing acrylic resin at the premolar -molar area.
Experimental: CAD CAM mandibular advancement device	Device: CAD CAM mandibular advancement device; 3D models for the stone casts were constructed with laser scanning machine (accuracy <20 µm; D500, 3shape). Maxillary and mandibular casts were rescanned in the achieved 75% advancement position and monoblock device was designed by CAD (computer-aided design) with 3D software (3-matic; Materialise) and printed by
Experimental: Uvuloplatopharyngeoplasty UPPP	Procedure: Uvuloplatopharyngeoplasty UPPP; uvulopalatopharyngeoplasty UPPP were performed by the same ENT surgeon under GA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apnea hypopnea index	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)	4 months
Epwoth sleeplness scale (ESS)	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.	4 months
Oxygen saturation	This will be measured using an oximeter. A normal level of oxygen is usually 95% or higher.	4 months
Snoring index	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	4 months

Collaborators and Investigators

• Sponsor: Nourhan M.Aly
• Investigators: Principal Investigator: Mona Sabry, PhD, Faculty of Dentistry, Alexandria University, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): January 1, 2024
• Study Completion (Actual): January 10, 2024

Study Registration Dates

• First Submitted: April 2, 2024
• First Submitted That Met QC Criteria: April 2, 2024
• First Posted (Actual): April 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 27, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: #1/2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No