ApneaNCT06352658
Efficacy of Different Treatments for Obstructive Sleep Apnea
A study testing Conventional mandibular advancement device, CAD CAM mandibular advancement device and Uvuloplatopharyngeoplasty UPPP in people with Apnea, run by Nourhan M.Aly at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Apnea
- What is being tested?
- Conventional mandibular advancement device, CAD CAM mandibular advancement device and Uvuloplatopharyngeoplasty UPPP
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 10 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
- Conventionally constructed mandibular advancement device (MAD).
- Digitally constructed mandibular advancement device (CAD CAM).
- Uvulopalatopharyngeoplasty (UPPP).
- Conditions
- Apnea
- Being tested
- Conventional mandibular advancement device, CAD CAM mandibular advancement device, Uvuloplatopharyngeoplasty UPPP
- Medical subject headings
- Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional mandibular advancement deviceDevice
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 deviceDevice
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 UPPPProcedure or surgery
uvulopalatopharyngeoplasty UPPP were performed by the same ENT surgeon under GA.
| Study group | Role | What they receive |
|---|---|---|
| Conventional mandibular advancement device | Active comparator | Not described Receives: Device: Conventional mandibular advancement device |
| CAD CAM mandibular advancement device | Experimental | Not described Receives: Device: CAD CAM mandibular advancement device |
| Uvuloplatopharyngeoplasty UPPP | Experimental | Not described Receives: Procedure: Uvuloplatopharyngeoplasty UPPP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 4 months
Oxygen saturation
This will be measured using an oximeter. A normal level of oxygen is usually 95% or higher.
Measured: 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
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start1 Feb 2023
- Primary completion1 Jan 2024
- Study completion10 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nourhan M.Aly
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nourhan M.Aly, University of Alexandria
- Investigators
- Mona Sabry, PhD, Principal investigator, Faculty of Dentistry, Alexandria University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06352658
- Sponsor's protocol ID
- #1/2024
- Status last verified
- Jan 2025
- First submitted
- 2 Apr 2024
- Last updated
- 30 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Different Treatment Modalities for Obstructive Sleep Apnea: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06352658
- Acronym / sponsor ID
- #1/2024
- Conditions
- Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Nourhan M.AlyUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 10 Jan 2024 (actual)
- First posted
- 8 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a prospective randomized controlled clinical trial that aimed to evaluate the efficacy of three treatments for obstructive sleep Apnea OSA:
- Conventionally constructed mandibular advancement device (MAD).
- Digitally constructed mandibular advancement device (CAD CAM).
- Uvulopalatopharyngeoplasty (UPPP).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional mandibular advancement deviceWith 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. | Device | Conventional mandibular advancement device |
| CAD CAM mandibular advancement device3D 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 | Device | CAD CAM mandibular advancement device |
| Uvuloplatopharyngeoplasty UPPPuvulopalatopharyngeoplasty UPPP were performed by the same ENT surgeon under GA. | Procedure or surgery | Uvuloplatopharyngeoplasty UPPP |
Primary outcome
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)
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.
Oxygen saturation
Time frame: 4 months
This will be measured using an oximeter. A normal level of oxygen is usually 95% or higher.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mona Sabry, PhD principal investigator
Faculty of Dentistry, Alexandria University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional mandibular advancement device, CAD CAM mandibular advancement device and Uvuloplatopharyngeoplasty UPPP in people with Apnea, run by Nourhan M.Aly at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea hypopnea index (time frame: 4 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.