NCT03720353

Pharmacological Intervention for Symptomatic Snoring

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

Currently, there is no pharmacological intervention capable of maintaining airway patency for the treatment of snoring and airflow limitation during sleep. Here we study the effect of pharmacological stimulation of the pharyngeal muscles on snoring severity, in a randomized quadruple-blind, crossover study.

Detailed description

Two active interventions are being studied and compared against placebo. Participants will therefore be randomized to one of six possible sequences. Washout periods will be 1 week. Effects of interventions on outcomes will be assessed using mixed effect model analyses: we will quantify the effect of active treatment 1 (referenced to placebo), the effect of active treatment 2 (referenced to placebo), adjusting for effects of time (period number), carryover effects, and baseline values (fixed effects). Participants are considered random effects. Primary outcome is based on significance of active intervention 1 versus placebo.

Conditions

• Snoring

Interventions

Type	Name	Description
DRUG	SAS2094AH and SAS2094BH	SAS2094AH and SAS2094BH for 7 days, preceded by SAS2094AL and SAS2094BH for 3 days.
DRUG	SAS2094AL and SAS2094BL	SAS2094AL and SAS2094BL for 10 days
DRUG	Placebo	Placebo for 10 days. Capsules will mimic active treatments.

Timeline

• Start date: 2018-12-17
• Primary completion: 2019-12-10
• Completion: 2019-12-10
• First posted: 2018-10-25
• Last updated: 2019-12-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study