Skip to content

Pharmacological Therapy for the treatment of Obstructive Sleep Apnea: a randomized clinical trial

Reboxetine and Oxybutynin for the treatment of Obstructive Sleep Apnea: a randomized clinical trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
REBEC
Registry ID
RBR-7w75qby
Enrollment
Unknown
Registered
2024-07-15
Start date
2024-09-01
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

Obstructive Sleep Apnea

Interventions

Randomized double blind controlled cross-over clinical trial, with four parallel arms. 36 patients divided into four arms will be included. In group A 9 patients will be randomized to start treatment
D03.383.533.640.682
D27.505.519.625.120.200

Sponsors

Departamento de Cirurgia da Universidade Federal do Rio Grande do Norte
Lead Sponsor
Departamento de Cirurgia da Universidade Federal do Rio Grande do Norte
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients aged 18 years or older diagnosed; both genders; with Obstructive Sleep Apnea according to the criteria of the American Academy of Sleep Medicine (AASM).

Exclusion criteria

Exclusion criteria: Pregnant patients; cognitive disorders that prevent understanding to provide consent and adequate use of proposed therapies; use of medications or drugs that have a known interaction with the proposed therapy; allergy to any of the components of the proposed therapies; angle-closure glaucoma; partial or total obstruction of the gastrointestinal tract; paralytic ileus; intestinal atony in the elderly; megacolon; toxic megacolon; complication of ulcerative colitis; severe colitis; myasthenia gravis; unstable cardiovascular status due to acute hemorrhage; obstructive uropathy or urinary retention

Design outcomes

Primary

MeasureTime frame
To evaluate the difference in the Apnea-Hypoapnea Index (AHI) between patients in the intervention group and control groups using polysomnography using the AHI

Secondary

MeasureTime frame
To assess daytime sleepiness using the Epworth sleepiness scale, quality of life using the FOSQ-10 questionnaire, and minimum saturation using polysomnography.

Countries

Brazil

Contacts

Public ContactMaria Nobre

Departamento de Cirurgia da Universidade Federal do Rio Grande do Norte

maria.lunobre@gmail.com+55(84)3342-5000

Outcome results

None listed

Source: REBEC (via WHO ICTRP)