Obstructive Sleep Apnea(MADs)NCT07003854
Effects of Mandibular Advancing Device in Obstructive Sleep Apnea
A study testing Mandibular advancement device in people with Obstructive Sleep Apnea, run by Ain Shams University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to learn if Mandibular advancing devices work to treat obstructive sleep apnea in adults. Selected Participants have a mild or moderate degree of obstructive sleep apnea.The main questions it aims to answer are: Do Mandibular advancing devices (MADs) lower the number of times… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Mandibular advancement device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2022to 15 Jan 2025
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults (18 years and older)
- Mild/Moderate obstructive sleep apnea
- Sufficient number of teeth( having at least one terminal molar)
- Healthy teeth and Periodontal ligament
- Good physical and mental capability helping the subjects to be able to deal with the appliance.
Who cannot join
- Severe OSA,
- Central sleep apnea,
- Pregnant females
- Somatic or psychological disease, or medications for psychological conditions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effects of Mandibular Advancing Device in Obstructive Sleep Apnea Patients
The goal of this clinical trial is to learn if Mandibular advancing devices work to treat obstructive sleep apnea in adults. Selected Participants have a mild or moderate degree of obstructive sleep apnea.The main questions it aims to answer are:
Do Mandibular advancing devices (MADs) lower the number of times participants experience apneas or hypopneas during sleep? Do MADs lower Apnea Hypopnea Index in adults when worn during sleep?
Read the detailed description
This clinical trial aims to evaluate comprehensively the effects of a custom made titrable bi-block mandibular advancing device on the respiratory variables in polysomnography. This includes the apnea hypopnea index and the oxygen desaturation index. Also sleep variables such as sleep efficiency and snoring duration are evaluated. Also cone beam computed tomography scans are taken before treatment and after 6 weeks of using te appliance. the second CBCT scan is taken with the appliance intra-orally. The cahnge in airway volume and minimal axial area are measured.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Mandibular advancement device
- Keywords
- Mandibular advancing device
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandibular advancement deviceDevice
Custom made titrable bi-bloc MADs worn during sleep to stabilize airway and treat obstructive sleep apnea
| Study group | Role | What they receive |
|---|---|---|
| mild-moderate obstructive sleep apnea subjects | Experimental | receiving mandibular advancing devices Receives: Device: Mandibular advancement device |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in AHI
difference between pre-tretment and post-treatment Apnea Hypopnea Index
Measured: frpm enrollment to assessment of outcomes at least 8weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start15 Jan 2022
- Primary completion15 Oct 2024
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rania Mohamed Magdy, lecturer, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07003854
- Sponsor's protocol ID
- Serial 901
- Acronym
- (MADs)
- Status last verified
- May 2025
- First submitted
- 22 May 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pre-treatment and post-treatment polsmnographic outcomes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Mandibular Advancing Device in Obstructive Sleep Apnea Patients
- ClinicalTrials.gov ID
- NCT07003854
- Acronym / sponsor ID
- (MADs) / Serial 901
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Mandibular advancing device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 4 Jun 2025 (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.
The goal of this clinical trial is to learn if Mandibular advancing devices work to treat obstructive sleep apnea in adults. Selected Participants have a mild or moderate degree of obstructive sleep apnea.The main questions it aims to answer are:
Do Mandibular advancing devices (MADs) lower the number of times participants experience apneas or hypopneas during sleep? Do MADs lower Apnea Hypopnea Index in adults when worn during sleep?
Detailed description
This clinical trial aims to evaluate comprehensively the effects of a custom made titrable bi-block mandibular advancing device on the respiratory variables in polysomnography. This includes the apnea hypopnea index and the oxygen desaturation index. Also sleep variables such as sleep efficiency and snoring duration are evaluated. Also cone beam computed tomography scans are taken before treatment and after 6 weeks of using te appliance. the second CBCT scan is taken with the appliance intra-orally. The cahnge in airway volume and minimal axial area are measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mild-moderate obstructive sleep apnea subjects | Experimental | Device: Mandibular advancement devicereceiving mandibular advancing devices |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adults (18 years and older)
- Mild/Moderate obstructive sleep apnea
- Sufficient number of teeth( having at least one terminal molar)
- Healthy teeth and Periodontal ligament
- Good physical and mental capability helping the subjects to be able to deal with the appliance.
Key exclusion criteria (4 listed)
- Severe OSA,
- Central sleep apnea,
- Pregnant females
- Somatic or psychological disease, or medications for psychological conditions.
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 |
|---|---|---|
| Mandibular advancement deviceCustom made titrable bi-bloc MADs worn during sleep to stabilize airway and treat obstructive sleep apnea | Device | mild-moderate obstructive sleep apnea subjects |
Primary outcome
change in AHI
Time frame: frpm enrollment to assessment of outcomes at least 8weeks
difference between pre-tretment and post-treatment Apnea Hypopnea Index
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 4 Jun 2025.
- Individual participant dataSharing planned: Yes. Pre-treatment and post-treatment polsmnographic outcomes
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
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DRonabinol Treatment of OSA
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RecruitingObservational study
Predictive Factors for Occlusal Changes in Obstructive Sleep Apnea Treatment With Mandibular Advancement Appliance
Obstructive Sleep Apnea Syndrome
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Use a Breathing Machine (PAP) (VESPER-OSA 1)
Apnea, Sleep Disorders
Active, not recruitingPhase 3
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity Who Are on Positive Airway Pressure Ventilation (PAP) Therapy
Subjects With Moderate-to-severe OSA and Obesity Who Are on PAP Therapy
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.
Rania Mohamed Magdy, lecturer principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mandibular advancement device in people with Obstructive Sleep Apnea, run by Ain Shams University 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 4 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 4 Jun 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?
change in AHI (time frame: frpm enrollment to assessment of outcomes at least 8weeks). 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 4 Jun 2025.