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Effect of respiratory therapy in adults with bruxism and respiratory dificult during sleep

Effect of respiratory therapy in adults with Bruxism patients and associeted respiratory events - N/A: N/A

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-9f6jkm
Enrollment
Unknown
Registered
2020-01-28
Start date
2020-02-15
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep obstructive apnea

Interventions

Inspiratory and expiratory therapy will be performed using the Phillips® brand Treshold imt and pep device respectively. This device uses a resistive load to increase endurance and inspiratory and exp
includes (i) a flow-independent one-way valve to ensure resistance and (ii) a specific adjustable pressure setting (in cmH20). Treshold Efficacy was tested in a 2019 study where OSA severity and dayti
the second experimental group with 10 adults (18 to 65 years) will undergo expiratory therapy
The placebo group with 10 adults (18 to 65 years) will perform inspiratory and expiratory therapy using the same equipment used by the experimental groups, but without impregnating the load.
Procedure/surgery
H02.010.625

Sponsors

Universidade Tuiuti do Paraná
Lead Sponsor
Universidade Tuiuti do Paraná
Collaborator

Eligibility

Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients aged 18 to 65 years; Patients identified with sleep bruxism and associated respiratory events (apnea and mild to moderate hypopnea) by polysomnography.

Exclusion criteria

Exclusion criteria: Use of intraoral device; Associated severe apnea / hypopnea; Severe skeletal changes affecting upper airways; Chronic medical conditions that affect OSAHS such as stroke; Failure to sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
Assessment of hypopnea apnea index (AHI) Breathing exercise promotes decreased AHI. ;Evaluate the number of masseter contractions per hour. Breathing exercise promotes decreased number of masseter contractions during sleep.

Secondary

MeasureTime frame
To assess sleep quality before and after respiratory intervention in these individuals.

Countries

Brazil

Contacts

Public ContactBianca Cavalcante-Leão

Universidade Tuiuti do Paraná

bianca.leao@utp.br+5541999410890

Outcome results

None listed

Source: REBEC (via WHO ICTRP)