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Evaluation of polysomnography data in the treatment of sleep respiratory disorders with intraoral language stabilization device: randomized clinical trial

Evaluation of polysomnographic parameters in the treatment of sleep-disordered breathing with tongue stabilizer: randomized clinical trial - SDBTTRD: sleep-disordered breathing treated with tongue retaining device

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5dy35n
Enrollment
Unknown
Registered
2019-01-24
Start date
2010-03-03
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 apnea

Interventions

experimental group: 32 patients will receive the lingual stabilizer. control group: 32 patients will receive an interocclusal plaque, pressed in acetate. The 64 patients will use for four weeks and wi
Device
E06.658.453.560.100
D26.660

Sponsors

Universidade Federal de São Paulo
Lead Sponsor
Fundação de Amparo à Pesquisa do Estado de São Paulo
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: patients with a polysomnographic diagnosis of mild or moderate OSAS; and who did not adapt or had no access to CPAP treatment

Exclusion criteria

Exclusion criteria: patients on drug treatments that may modify muscle tone; alcohol users in their daily routin;, involved in any other type of treatment for OSA; or patients who were pregnant

Design outcomes

Primary

MeasureTime frame
Check if the apnea-hypopnea index reduces to less than 5 events per hour—

Secondary

MeasureTime frame
To verify the improvement of polysomnographic parameters;to evaluate adverse events with the use of the lingual stabilizer—

Countries

Brazil

Contacts

Public ContactLuciane;Luciane de Carvalho;Carvalho

Universidade Federal de São Paulo;Universidade Federal de São Paulo

neuro.sono.unifesp@gmail.com;neuro.sono.unifesp@gmail.com11 50816629;+55-011-50816629

Outcome results

None listed

Source: REBEC (via WHO ICTRP)