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

Phase 2

• Conditions: Obstructive Sleep Apnea

• Registration Number: RBR-7w75qby
• Lead Sponsor: Departamento de Cirurgia da Universidade Federal do Rio Grande do Norte

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-15
• Last Update Posted: 22 July 2024
• Study Completion: 2025-04-07

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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