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Treatment of obstructive sleep apnea in the elderly with intraoral appliance

Treatment of obstructive sleep apnea in the elderly with low-cost intraoral appliance: a multicentric study - ORACLE 2 Oral appliances for sleep apnea of the elderly - 2

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
REBEC
Registry ID
RBR-44y22nj
Enrollment
Unknown
Registered
2021-11-12
Start date
2020-01-06
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, Obstructive

Interventions

Experimental group: 47 people will receive a soft dental appliance made of silicone for use only during sleep for 60 days. Control group: 47 people will receive a rigid dental appliance made of acryl
D009968

Sponsors

FAPERGS - Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul
Lead Sponsor
UFRGS - Universidade Federal do Rio Grande do Sul
Collaborator

Eligibility

Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: Healthy volunteers; both genders; aged 65 years or older.

Exclusion criteria

Exclusion criteria: Volunteer with less than 8 teeth in the lower jaw; dental implants installed less than 6 months ago; mouth breathers; mouth opening less than 30mm; temporomandibular joint pain or dysfunction; facial anomalies or neoplasms; absence of sleep apnea or severe apnea (score 30 or more); diagnoses of cardiac, hepatic, pulmonary, neurological or psychiatric pathologies.

Design outcomes

Primary

MeasureTime frame
Decrease in the apnea and hypopnea index to at least 10, measured by respiratory polygraphy after 60 days of use of the intraoral device.

Secondary

MeasureTime frame
Aumento de pelo menos 10% do volume da via aérea superior, medido em tomografia computadorizada de feixe cônico obtida após 60 dias de uso do aparelho intraoral, em comparação ao exame inicial.

Countries

Brazil

Contacts

Public ContactVania Regina Fontanella
vaniafontanella@terra.com.br+55-51-981166838

Outcome results

None listed

Source: REBEC (via WHO ICTRP)