Minimum Effective Dose-Finding Study of BF2.649, in Patients With Moderate to Severe OSA, Experiencing EDS Despite Regular Use of nCPAP, and Patients Having Refused This Therapy - Randomized, Double Blind Study With BF2.649 or Placebo
Abstract
Prospective, multicenter, double-blind, phase II, randomized, dose-response study in 5 parallel groups (dose-range).
Conditions: Obstructive Sleep Apnoea, Excessive Daytime Sleepiness.
Primary outcome: Change in Epworth Sleepiness Scale scores (ESS).
Enrollment: 110 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 110 participants or records.
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