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Effect Of Sleep Apnea Treatment On Temporo-Mandibular Disorders

Primary Purpose

Sleep Apnea, Sleep Apnea, Obstructive, Sleep Apnea Syndromes

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
osa treatment
no treatment
Sponsored by
Anna Alessandri Bonetti
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea focused on measuring pain, sleep apnea, temporo-mandibular disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients suffering from OSA diagnosed by polysomnography not yet undergoing treatment

Exclusion Criteria:

  • patients presenting some kind of cognitive impairment, due to difficulties in undergoing TMD examination
  • patients presenting dental problems
  • patients assuming medications that would alter pain perception
  • patients not signing the informed consent

Sites / Locations

  • Policlinico Universitario A. Gemelli IRCCS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

treatment

no treatment

Arm Description

Outcomes

Primary Outcome Measures

variation in TMD prevalence according to diagnostic criteria for temporo-mandibular disorders
prevalence described as percentage of people having the disease

Secondary Outcome Measures

reduction of TMD signs according to diagnostic criteria for temporo-mandibular disorder
reduction described as percentage of people resolving the disease
reduction of TMD symptoms according to diagnostic criteria for temporo-mandibular disorder
reduction in pain described by patients through a numeric rating scale going from 0 to 10, were 0 is no pain and 10 is the worst immaginabile pain

Full Information

First Posted
June 17, 2021
Last Updated
July 28, 2021
Sponsor
Anna Alessandri Bonetti
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1. Study Identification

Unique Protocol Identification Number
NCT04948541
Brief Title
Effect Of Sleep Apnea Treatment On Temporo-Mandibular Disorders
Official Title
Effect Of Sleep Apnea Treatment On Temporo-Mandibular Disorders In Patients Suffering From Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
April 21, 2021 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
July 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Anna Alessandri Bonetti

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Aims of this research are to detect if an improvement in sleep pattern in patients suffering from obstructive sleep apnea (OSA), produces a reduction in pain and dysfunction in the orofacial area by examining variation in temporo-mandibular disorder (TMD) signs and symptoms and if the prevalence of TMDs in OSA patients controlling this disease decreases to levels comparable to healthy subjects. 41 OSA patients will undergo a complete TMD examination prior to start any OSA treatment and after at least 18 months of therapy. Variations in TMD signs and symptoms will be recorded.
Detailed Description
Since a bidirectional relationship has been suggested for poor sleep and pain and considering that patients suffering from obstructive sleep apnea (OSA) have been reported to present a higher prevalence of temporo-mandibular disorder (TMD) signs and symptoms compared to healthy controls; aims of this research are to detect if an improvement in sleep pattern in patients suffering from OSA, produces a reduction in pain and dysfunction in the orofacial area by examining variation in TMD signs and symptoms and if the prevalence of TMDs in OSA patients controlling this disease decreases to levels comparable to healthy subjects. 41 OSA patients will undergo a complete TMD examination prior to start any OSA treatment and after at least 18 months of therapy. Variations in TMD signs and symptoms will be recorded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Pain, Pain, Face, Temporomandibular Disorder
Keywords
pain, sleep apnea, temporo-mandibular disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
treatment
Arm Type
Experimental
Arm Title
no treatment
Arm Type
Experimental
Intervention Type
Combination Product
Intervention Name(s)
osa treatment
Intervention Description
different treatments can be included
Intervention Type
Other
Intervention Name(s)
no treatment
Intervention Description
no treatment was undergone
Primary Outcome Measure Information:
Title
variation in TMD prevalence according to diagnostic criteria for temporo-mandibular disorders
Description
prevalence described as percentage of people having the disease
Time Frame
change from baseline temporo-mandibular disorders at 18 months
Secondary Outcome Measure Information:
Title
reduction of TMD signs according to diagnostic criteria for temporo-mandibular disorder
Description
reduction described as percentage of people resolving the disease
Time Frame
change from baseline temporo-mandibular disorder signs at 18 months
Title
reduction of TMD symptoms according to diagnostic criteria for temporo-mandibular disorder
Description
reduction in pain described by patients through a numeric rating scale going from 0 to 10, were 0 is no pain and 10 is the worst immaginabile pain
Time Frame
change from baseline temporo-mandibular disorder symptoms at 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients suffering from OSA diagnosed by polysomnography not yet undergoing treatment Exclusion Criteria: patients presenting some kind of cognitive impairment, due to difficulties in undergoing TMD examination patients presenting dental problems patients assuming medications that would alter pain perception patients not signing the informed consent
Facility Information:
Facility Name
Policlinico Universitario A. Gemelli IRCCS
City
Roma
State/Province
RM
ZIP/Postal Code
00168
Country
Italy

12. IPD Sharing Statement

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Effect Of Sleep Apnea Treatment On Temporo-Mandibular Disorders

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