NCT04394143

Effect of AD128 to Treat Obstructive Sleep Apnea

Effect of AD128 on Obstructive Sleep Apnea Severity: a Randomized, Placebo-controlled, Double-blind, Cross-over Study

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Raphael Heinzer · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the combination of two drugs (AD128), to treat obstructive sleep apnea (OSA) severity. After a baseline evaluation and during 7 days, half of the participants will randomly receive this drug combination (AD128) and the other will receive a placebo, i.e. a drug without pharmaceutical effect. Neither the participants, nor the investigators will know in which arm participants are until the end of the study. After one week of trial, an evaluation will be perform and will be follow by one week without any treatment. During the third and last week of trial, there will be a crossover of the groups, i.e. the participants of the first group who took the two drugs (AD128) during the first week will take a placebo and those who took the placebo will take the drugs combination.

Conditions

• Sleep Apnea, Obstructive

Interventions

Type	Name	Description
DRUG	AD128	Oral administration of two capsules before sleep for 7 days.
DRUG	Mannitol	Oral administration of two capsules before sleep for 7 days.

Timeline

• Start date: 2020-10-20
• Primary completion: 2021-07-19
• Completion: 2021-07-19
• First posted: 2020-05-19
• Last updated: 2021-08-06

Locations

1 site across 1 country: Switzerland