Diaphragmatic Breathing for Sleep Bruxism in Adults: A Randomized Controlled Trial

NCT ID: NCT07181642

Last Updated: 2025-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-15

Study Completion Date

2025-11-14

Brief Summary

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The goal of this clinical trial is to learn if a diaphragmatic breathing program can reduce sleep bruxism in adults. The main questions it aims to answer are:

Can diaphragmatic breathing lower the frequency of teeth grinding during sleep?

Can it reduce jaw discomfort and improve sleep quality?

Participants will:

Attend sessions to learn diaphragmatic breathing exercises

Practice these exercises daily at home for 4 weeks

Complete questionnaires and clinical assessments before and after the program

Participation is safe, with minimal risks, such as mild fatigue during exercises. The study will help determine if diaphragmatic breathing is an effective way to manage sleep bruxism

Detailed Description

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Conditions

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Bruxism Bruxism, Sleep-Related

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Experimental Group - Diaphragmatic Breathing

Participants will learn and practice diaphragmatic breathing exercises daily for 4 weeks.

Group Type EXPERIMENTAL

Diaphragmatic Breathing Program

Intervention Type BEHAVIORAL

Participants will learn diaphragmatic breathing exercises and practice them daily for 4 weeks before bedtime.

Placebo Group

Participants will listen to neutral music of the same duration before sleep. This activity does not include any therapeutic breathing exercises and is intended as a control.

Group Type PLACEBO_COMPARATOR

Neutral Music Listening

Intervention Type BEHAVIORAL

Participants will listen to neutral music of the same duration before sleep. This activity does not include any therapeutic breathing exercises and is intended as a control

Interventions

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Diaphragmatic Breathing Program

Participants will learn diaphragmatic breathing exercises and practice them daily for 4 weeks before bedtime.

Intervention Type BEHAVIORAL

Neutral Music Listening

Participants will listen to neutral music of the same duration before sleep. This activity does not include any therapeutic breathing exercises and is intended as a control

Intervention Type BEHAVIORAL

Other Intervention Names

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Deep Breathing Exercises placebo

Eligibility Criteria

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Inclusion Criteria

* Clinically diagnosed sleep bruxism
* Provision of consent

Exclusion Criteria

* • Current use of medications affecting sleep or neuromuscular function

* History of severe neurological or psychiatric disorders
* Ongoing use of a dental reconditioning splint or occlusal device
* Inability to informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Monastir

OTHER

Sponsor Role lead

Responsible Party

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Chtioui Hajer

Assistant, Removable Partial Dentures

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Habib Bougatfa Bizerte

Bizerte, , Tunisia

Site Status

Countries

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Tunisia

Other Identifiers

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DB-SB-RCT-2025

Identifier Type: -

Identifier Source: org_study_id

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