Obstructive Sleep Apnea of AdultNCT06492096
Bibloc Mandibular Advancement Oral Device and Its Effect on TMJ Health
A study testing Bibloc Mandibular Advancement device in people with Obstructive Sleep Apnea of Adult, run by Mansoura University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to learn if Mandibular Advancement Device( MAD) works to treat Obstructive sleep apnea in adults. It will also learn about the effect of the device on the Tempromandibular Joint Health . Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Obstructive Sleep Apnea of Adult
- What is being tested?
- Bibloc Mandibular Advancement device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2022to 30 May 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
- Patients having obstructive sleep apnea syndrome (OSAS) as determined by polysomnography with mild to moderate apnea/hypopnea index ranging from 5 to 30 events per hour of sleep. ( As 5-15 events per hour is considered mild condition, 16-30 is considered moderate).(1)
- 2- Adequate nasal air flow capacity as determined by qualified otolaryngologist.
Who cannot join
- patients having Central sleep apnea events as determined by the polysomnography.
- 2- patients having cardiovascular disease. 3- History of alcohol, narcotic or psychoactive medications. 4- Serious nasal passage obstructions or allergies. 5- Previous history of treatment with any type of obstructive sleep apnea oral appliances.
- 6- Obese patients with BMI more than 30. 7- Missing more than five teeth (excluding third molar). 8- Allergy to acrylic resin.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of dentistry, Mansoura university
Al Manşūrah, Ad Dakahlia, 35511
About this study
Official title: Relation Between Bibloc Mandibular Advancement Oral Appliance Used In Treatment of Obstructive Sleep Apnea and Tempromandibular Joint Health
The goal of this clinical trial is to learn if Mandibular Advancement Device( MAD) works to treat Obstructive sleep apnea in adults. It will also learn about the effect of the device on the Tempromandibular Joint Health . The main questions it aims to answer are:
Does MAD lower the number of apnoea and hypopnea participants suffer from during sleep? Would it cause any effect on TMJ health? Researchers will compare between a group of TMD patients with OSA to a non_TMD group of patients also with sleep apnea and both groups will receive a Bibloc MADplacebo (a look-alike substance that contains no drug) to see if it affect the TMJ health.
Read more
Participants will:
Wear MAD during sleep (at least 6 hours) every day for 6 months Visit the clinic once after the first week for checkups and adjustment of MAD If needed and then after 3 months and 6 months.
Polysomnography, MRI, and tmd screening was done before the appliance insertion and after 6 months of its insertion.
- Conditions
- Obstructive Sleep Apnea of Adult
- Being tested
- Bibloc Mandibular Advancement device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bibloc Mandibular Advancement deviceDevice
Each patient received a CAD/CAM designed Bibloc Mandibular Advancement device
| Study group | Role | What they receive |
|---|---|---|
| TMD Group | Active comparator | Not described Receives: Device: Bibloc Mandibular Advancement device |
| Non_TMD Group | Active comparator | Not described Receives: Device: Bibloc Mandibular Advancement device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea/Hypopnea index
Number of apnea and hypopnea per hour of sleep
Measured: 6 months
Secondary outcomes (2)
Condylar disc position
It appears in MRI and measured before and after the appliance insertion
Measured: 6 months
Joint space of TMJ
measurement of joint space was done for each patient on their MRI before and after the treatment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start15 Jun 2022
- Primary completion23 Apr 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea of AdultStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06492096
- Sponsor's protocol ID
- M06050422
- Status last verified
- Apr 2022
- First submitted
- 1 Jul 2024
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation Between Bibloc Mandibular Advancement Oral Appliance Used In Treatment of Obstructive Sleep Apnea and Tempromandibular Joint Health
- ClinicalTrials.gov ID
- NCT06492096
- Acronym / sponsor ID
- M06050422
- Conditions
- Obstructive Sleep Apnea of Adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 23 Apr 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 9 Jul 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.
The goal of this clinical trial is to learn if Mandibular Advancement Device( MAD) works to treat Obstructive sleep apnea in adults. It will also learn about the effect of the device on the Tempromandibular Joint Health . The main questions it aims to answer are:
Does MAD lower the number of apnoea and hypopnea participants suffer from during sleep? Would it cause any effect on TMJ health? Researchers will compare between a group of TMD patients with OSA to a non_TMD group of patients also with sleep apnea and both groups will receive a Bibloc MADplacebo (a look-alike substance that contains no drug) to see if it affect the TMJ health.
Participants will:
Wear MAD during sleep (at least 6 hours) every day for 6 months Visit the clinic once after the first week for checkups and adjustment of MAD If needed and then after 3 months and 6 months.
Polysomnography, MRI, and tmd screening was done before the appliance insertion and after 6 months of its insertion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TMD Group | Active comparator | Device: Bibloc Mandibular Advancement device |
| Non_TMD Group | Active comparator | Device: Bibloc Mandibular Advancement device |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients having obstructive sleep apnea syndrome (OSAS) as determined by polysomnography with mild to moderate apnea/hypopnea index ranging from 5 to 30 events per hour of sleep. ( As 5-15 events per hour is considered mild condition, 16-30 is considered moderate).(1)
- 2- Adequate nasal air flow capacity as determined by qualified otolaryngologist.
Key exclusion criteria (3 listed)
- patients having Central sleep apnea events as determined by the polysomnography.
- 2- patients having cardiovascular disease. 3- History of alcohol, narcotic or psychoactive medications. 4- Serious nasal passage obstructions or allergies. 5- Previous history of treatment with any type of obstructive sleep apnea oral appliances.
- 6- Obese patients with BMI more than 30. 7- Missing more than five teeth (excluding third molar). 8- Allergy to acrylic resin.
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 |
|---|---|---|
| Bibloc Mandibular Advancement deviceEach patient received a CAD/CAM designed Bibloc Mandibular Advancement device | Device | Non_TMD Group, TMD Group |
Primary outcome
Apnea/Hypopnea index
Time frame: 6 months
Number of apnea and hypopnea per hour of sleep
2 secondary outcomes
Condylar disc position
Time frame: 6 months
Joint space of TMJ
Time frame: 6 months
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 9 Jul 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bibloc Mandibular Advancement device in people with Obstructive Sleep Apnea of Adult, run by Mansoura 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 2 inclusion and 3 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 9 Jul 2024. 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: 6 months). 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 9 Jul 2024.