BruxismDB4SBNCT07181642
Diaphragmatic Breathing for Sleep Bruxism in Adults: A Randomized Controlled Trial
A study testing Diaphragmatic Breathing Program and Neutral Music Listening in people with Bruxism and Bruxism, Sleep-Related, run by University of Monastir at 1 site in Tunisia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Bruxism, Bruxism, Sleep-Related
- What is being tested?
- Diaphragmatic Breathing Program and Neutral Music Listening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTunisia
- Study dates
- 15 Sep 2025to 14 Nov 2025
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Clinically diagnosed sleep bruxism
- Provision of consent
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Diaphragmatic Breathing Program in Adults With Sleep Bruxism: A Randomized Controlled Trial
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
- Conditions
- Bruxism, Bruxism, Sleep-Related
- Being tested
- Diaphragmatic Breathing Program, Neutral Music Listening
- Medical subject headings
- Bruxism, Sleep Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragmatic Breathing ProgramBehavioural
Also called Deep Breathing Exercises
Participants will learn diaphragmatic breathing exercises and practice them daily for 4 weeks before bedtime.
Neutral Music ListeningBehavioural
Also called placebo
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
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group - Diaphragmatic Breathing | Experimental | Participants will learn and practice diaphragmatic breathing exercises daily for 4 weeks. Receives: Behavioral: Diaphragmatic Breathing Program |
| Placebo Group | Placebo comparator | 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. Receives: Behavioral: Neutral Music Listening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Bruxism Frequency
The frequency of sleep bruxism episodes will be assessed using the standardized STAB questionnaire and patient self-reports. Measurements will be taken at baseline (before starting the intervention) and at the end of the 4-week program to determine any change in bruxism frequency.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start15 Sep 2025
- Primary completion30 Oct 2025
- Study completion14 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BruxismStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chtioui Hajer, University of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07181642
- Sponsor's protocol ID
- DB-SB-RCT-2025
- Acronym
- DB4SB
- Status last verified
- Nov 2025
- First submitted
- 11 Sep 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Diaphragmatic Breathing Program in Adults With Sleep Bruxism: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07181642
- Acronym / sponsor ID
- DB4SB / DB-SB-RCT-2025
- Conditions
- Bruxism, Bruxism, Sleep-Related
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 14 Nov 2025 (actual)
- First posted
- 18 Sep 2025 (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 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group - Diaphragmatic Breathing | Experimental | Behavioral: Diaphragmatic Breathing ProgramParticipants will learn and practice diaphragmatic breathing exercises daily for 4 weeks. |
| Placebo Group | Placebo comparator | Behavioral: Neutral Music ListeningParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Clinically diagnosed sleep bruxism
- Provision of consent
Key exclusion criteria (4 listed)
- • Current use of medications affecting sleep or neuromuscular function
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 |
|---|---|---|
| Diaphragmatic Breathing ProgramAlso: Deep Breathing ExercisesParticipants will learn diaphragmatic breathing exercises and practice them daily for 4 weeks before bedtime. | Behavioural | Experimental Group - Diaphragmatic Breathing |
| Neutral Music ListeningAlso: placeboParticipants 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 | Behavioural | Placebo Group |
Primary outcome
Sleep Bruxism Frequency
Time frame: 4 weeks
The frequency of sleep bruxism episodes will be assessed using the standardized STAB questionnaire and patient self-reports. Measurements will be taken at baseline (before starting the intervention) and at the end of the 4-week program to determine any change in bruxism frequency.
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 19 Nov 2025.
- Individual participant dataSharing planned: Undecided
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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 Diaphragmatic Breathing Program and Neutral Music Listening in people with Bruxism and Bruxism, Sleep-Related, run by University of Monastir at 1 site in Tunisia.
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 4 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 19 Nov 2025. 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 Tunisia. 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. Some participants in this study may receive a placebo. 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?
Sleep Bruxism Frequency (time frame: 4 weeks). 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 19 Nov 2025.