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Completed

NCT Number: NCT06352658

Efficacy of Different Treatments for Obstructive Sleep Apnea

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).

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Key information

Conditions

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

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Alexandria University, Egypt

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Uvuloplatopharyngeoplasty UPPP

Procedure

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

Primary outcomes

  1. Apnea hypopnea index

    Time frame: 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)

  2. Epwoth sleeplness scale (ESS)

    Time frame: 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.

  3. Oxygen saturation

    Time frame: 4 months

    This will be measured using an oximeter. A normal level of oxygen is usually 95% or higher.

  4. Snoring index

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Nourhan M.Aly

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 8, 2024
Registry last updated
Jan 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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