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The use of Botox in the masticatory and throat musculature as a treatment of sleep apnea: a pilot study

The use of botulinum toxin in the masticatory and constrictor musculature of the pharynx as an option in the treatment of obstructive sleep apnea: a pilot study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9pr8j3x
Enrollment
Unknown
Registered
2023-10-12
Start date
2023-05-22
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

This is a pilot study of a clinical trial whose sample will be composed of 15 individuals (5 with mild obstructive sleep apnea, 5 with moderate obstructive sleep apnea, and 5 with severe obstructive s

Sponsors

Hospital Universitário Gaffrée e Guinle
Lead Sponsor
Hospital Universitário Gaffrée e Guinle
Collaborator

Eligibility

Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Age equal to or greater than 18 years old up to 60 years old; both genders; with a diagnosis of mild or moderate or severe obstructive sleep apnea gravity; body mass index<32; tonsils with grade I or II; the presence of Modified Mallampati I or II

Exclusion criteria

Exclusion criteria: Facial deformities; grade III or IV tonsils or adenoid hypertrophy greater than 50% or tumors; modified Mallampati III or IV; nasal obstruction that requires surgical treatment

Design outcomes

Primary

MeasureTime frame
Differences of apnea-hypopnea index of type 1 polysomnography before and after botulinum toxin

Secondary

MeasureTime frame
There are no secondary outcomes

Countries

Brazil

Contacts

Public ContactAna Carolina Ottoline

Hospital Universitário Gaffrée e Guinle

carol_ottoline@yahoo.com.br+55(21)22645844

Outcome results

None listed

Source: REBEC (via WHO ICTRP)