NCT04611750

Pharmacological Intervention for Symptomatic Mild Sleep Disordered Breathing

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 25 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Currently, there is no pharmacological intervention for mild symptomatic obstructive sleep disordered breathing (SDB) in the form of loud habitual snoring, inspiratory flow limitation (i.e. upper airway resistance syndrome), or mild sleep apnea. Here the investigators study the effect on SDB of stimulating pharyngeal muscles during sleep with AD036. The key hypothesis of the study is that AD036 is superior to placebo on self-reported and objective measures of SDB severity.

Detailed description

This is a randomized placebo-controlled 2-period crossover study. Each crossover period will consist of 14 days of QHS dosing of either AD036 or placebo, with a washout period of 7 days between each period. Polysomnography will be performed at screening (baseline) and on the last dosing day of each of the two crossover dosing period. The trial will enroll participants until a total of 24 responders are randomized into the crossover portion of the study.

Conditions

• Sleep Disordered Breathing

Interventions

Type	Name	Description
DRUG	AD036	AD036 will be given for 14 days
DRUG	Placebo	Placebo will be given for 14 days

Timeline

• Start date: 2020-12-02
• Primary completion: 2022-01-18
• Completion: 2022-01-18
• First posted: 2020-11-02
• Last updated: 2022-03-02

Locations

2 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study