Obstructive Sleep ApneaNCT05510882
Effects of Different Treatment Modalities for Obstructive Sleep Apnea on Temporomandibular Joint
A study testing different treatment modalities for OSA in people with Obstructive Sleep Apnea, run by Mansoura University at 1 site in Egypt.
Trial summary
this study aims to evaluate the subjective symptoms, clinical and radiographic signs of temporomandibular disorders related to the use of CPAP, MAD and physical therapy in the treatment of patients with obstructive sleep apnea. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- different treatment modalities for OSA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2022to 5 Aug 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • All adult patients, diagnosed as having OSA after full night polysomnography.
Who cannot join
- • Pregnant patients
Trial locations and contacts
1 site in 1 country.
About this study
this study aims to evaluate the subjective symptoms, clinical and radiographic signs of temporomandibular disorders related to the use of CPAP, MAD and physical therapy in the treatment of patients with obstructive sleep apnea.
Read the detailed description
The study will be conducted on thirty-nine patients with OSA attending to sleep disorders breathing Unit, Chest Department at Mansoura University Hospital confirmed by polysomnography in the period between July and September 2022. The patients will be divided equally into three therapy groups each compromise 13 patients:
Group I: patients will be treated with CPAP. Group II: patients will be treated with digitally fabricated MAD. Group II: patients will be treated with physical therapy.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- different treatment modalities for OSA
- Keywords
- Obstructive sleep apnea, tempromandibular joint
- 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.
different treatment modalities for OSAOther
Also called treatment
Group I: patients will be treated with CPAP. Group II: patients will be treated with digitally fabricated MAD. Group II: patients will be treated with physical therapy.
| Study group | Role | What they receive |
|---|---|---|
| three groups of different treatment modalities for OSA | Other | Group I: patients were treated with CPAP. Group II: patients were treated with digitally fabricated MAD. Group iII: patients were treated with oral myofunctional therapy. Receives: Other: different treatment modalities for OSA |
What is being measured
The primary outcome is the main question the study is designed to answer.
This study aims to assess signs of temporomandibular disorders related to the use of CPAP, MAD and physical therapy in the treatment of patients with OSA.
Pain scoring will be measured through a visual analogue scale (VAS) with 0 scores for no pain and 10 scores for worst pain experien Clicking was assessed as to its presence=1 or absence=0 The maximal unassisted, pain-free mouth opening will be measured in millimeters using a Vernier caliper Lateral movements: will be measured as the horizontal distance extending from maxillary midline to mandibular midline in millimeters using Vernier caliper All measurements record will be considered as a baseline to be used in comparison with 3 months post-treatment records
Measured: up to four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start1 Jul 2022
- Primary completion1 Aug 2022
- Study completion5 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 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
- NCT05510882
- Sponsor's protocol ID
- not sponsered
- Status last verified
- Aug 2022
- First submitted
- 8 Aug 2022
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study will be conducted on thirty-nine patients with OSA attending to sleep disorders breathing Unit, Chest Department at Mansoura University Hospital confirmed by polysomnography in the period between July and September 2022.
Publications
Attia AAMM, Awad SS, Mansour M, Baz H, Zahran KM, Saleh AM. Effects of different treatments for obstructive sleep apnea on temporomandibular joint: a randomized clinical trial. BMC Oral Health. 2024 Aug 11;24(1):931. doi: 10.1186/s12903-024-04623-w.
PubMed 39129005
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Treatment Modalities for Obstructive Sleep Apnea on Temporomandibular Joint
- ClinicalTrials.gov ID
- NCT05510882
- Acronym / sponsor ID
- not sponsered
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive sleep apnea, tempromandibular joint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 5 Aug 2022 (actual)
- First posted
- 22 Aug 2022 (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 study aims to evaluate the subjective symptoms, clinical and radiographic signs of temporomandibular disorders related to the use of CPAP, MAD and physical therapy in the treatment of patients with obstructive sleep apnea.
Detailed description
The study will be conducted on thirty-nine patients with OSA attending to sleep disorders breathing Unit, Chest Department at Mansoura University Hospital confirmed by polysomnography in the period between July and September 2022. The patients will be divided equally into three therapy groups each compromise 13 patients:
Group I: patients will be treated with CPAP. Group II: patients will be treated with digitally fabricated MAD. Group II: patients will be treated with physical therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| three groups of different treatment modalities for OSA | Other | Other: different treatment modalities for OSAGroup I: patients were treated with CPAP. Group II: patients were treated with digitally fabricated MAD. Group iII: patients were treated with oral myofunctional therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- • All adult patients, diagnosed as having OSA after full night polysomnography.
Key exclusion criteria (1 listed)
- • Pregnant patients
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 |
|---|---|---|
| different treatment modalities for OSAAlso: treatmentGroup I: patients will be treated with CPAP. Group II: patients will be treated with digitally fabricated MAD. Group II: patients will be treated with physical therapy. | Other | three groups of different treatment modalities for OSA |
Primary outcome
This study aims to assess signs of temporomandibular disorders related to the use of CPAP, MAD and physical therapy in the treatment of patients with OSA.
Time frame: up to four months
Pain scoring will be measured through a visual analogue scale (VAS) with 0 scores for no pain and 10 scores for worst pain experien Clicking was assessed as to its presence=1 or absence=0 The maximal unassisted, pain-free mouth opening will be measured in millimeters using a Vernier caliper Lateral movements: will be measured as the horizontal distance extending from maxillary midline to mandibular midline in millimeters using Vernier caliper All measurements record will be considered as a baseline to be used in comparison with 3 months post-treatment records
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 11 Apr 2023.
- Derived from this study: PubMed 39129005Attia AAMM, Awad SS, Mansour M, Baz H, Zahran KM, Saleh AM. Effects of different treatments for obstructive sleep apnea on temporomandibular joint: a randomized clinical trial. BMC Oral Health. 2024 Aug 11;24(1):931. doi: 10.1186/s12903-024-04623-w.
- Individual participant dataSharing planned: No. The study will be conducted on thirty-nine patients with OSA attending to sleep disorders breathing Unit, Chest Department at Mansoura University Hospital confirmed by polysomnography in the period between July and September 2022.
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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 different treatment modalities for OSA in people with Obstructive Sleep Apnea, 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 1 inclusion and 1 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 11 Apr 2023. 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?
This study aims to assess signs of temporomandibular disorders related to the use of CPAP, MAD and physical therapy in the treatment of patients with OSA. (time frame: up to four months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05510882, which also lists 1 linked publication.
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 11 Apr 2023.