NCT05510882

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2022

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 22, 2022

Completed
Last Updated

April 11, 2023

Status Verified

August 1, 2022

Enrollment Period

1 month

First QC Date

August 8, 2022

Last Update Submit

April 7, 2023

Conditions

Keywords

Obstructive sleep apneatempromandibular joint

Outcome Measures

Primary Outcomes (1)

  • 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

    up to four months

Study Arms (1)

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.

Other: different treatment modalities for OSA

Interventions

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.

Also known as: treatment
three groups of different treatment modalities for OSA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All adult patients, diagnosed as having OSA after full night polysomnography.

You may not qualify if:

  • Pregnant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University

Al Mansurah, Egypt

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2022

First Posted

August 22, 2022

Study Start

July 1, 2022

Primary Completion

August 1, 2022

Study Completion

August 5, 2022

Last Updated

April 11, 2023

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

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.

Locations