Efficacy of Different Treatments for Obstructive Sleep Apnea

NCT06352658 | Completed

• 1 other identifier: #1/2024
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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. 1.Conventionally constructed mandibular advancement device (MAD).
2. 2.Digitally constructed mandibular advancement device (CAD CAM).
3. 3.Uvulopalatopharyngeoplasty (UPPP).

Conditions

Apnea

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

Conventional mandibular advancement device

ACTIVE COMPARATOR

Device: Conventional mandibular advancement device

CAD CAM mandibular advancement device

EXPERIMENTAL

Device: CAD CAM mandibular advancement device

Uvuloplatopharyngeoplasty UPPP

EXPERIMENTAL

Procedure: Uvuloplatopharyngeoplasty UPPP

Interventions

Conventional mandibular advancement device 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.

Conventional mandibular advancement device

CAD CAM mandibular advancement device 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

CAD CAM mandibular advancement device

Uvuloplatopharyngeoplasty UPPP PROCEDURE

uvulopalatopharyngeoplasty UPPP were performed by the same ENT surgeon under GA.

Uvuloplatopharyngeoplasty UPPP

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nourhan M.Aly: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University, Egypt

Alexandria, Egypt

Location

MeSH Terms

Conditions

Apnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mona Sabry, PhD

  Faculty of Dentistry, Alexandria University, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer of Dental Public Health

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 8, 2024
• Study Start: February 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 10, 2024
• Last Updated: January 30, 2025

Record last verified: 2025-01

Locations

EG (1)