Pharmacological Intervention for Symptomatic Snoring

Phase 1

Completed

• Conditions: Snoring
• Interventions: Drug: SAS2094AL and SAS2094BL; Drug: SAS2094AH and SAS2094BH; Drug: Placebo

• Registration Number: NCT03720353
• Lead Sponsor: Brigham and Women's Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2018-10-24
• Study First Submitted QC: 2018-10-24
• Study First Posted: 2018-10-25
• Study Start: 2018-12-17
• Status Verified: 2019-12
• Primary Completion: 2019-12-10
• Study Completion: 2019-12-10
• Last Update Submitted: 2019-12-10
• Last Update Posted: 2019-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active L	SAS2094AL and SAS2094BL	Participants will take SAS2094AL and SAS2094BL for 10 days
Active H	SAS2094AH and SAS2094BH	Participants will take SAS2094AL and SAS2094BH for 3 days, then SAS2094AH and SAS2094BH for 7 days.
Placebo	Placebo	Participants will take placebo for 10 days.

Primary Outcome Measures

Name	Time	Method
Snoring intensity	1 week	mean tracheal snoring sound intensity (tracheal microphone), decibels

Secondary Outcome Measures

Name	Time	Method
Functional Outcomes of Sleep Questionnaire	1 week	30 items, units on a scale
Stage 1 Sleep	1 week	%Total sleep time
Arousal index	1 week	events per hour of total sleep time
Visual-Analog Scale for Treatment Satisfaction	1 week	0-10 scale
Epworth Sleepiness Scale	1 week	units on a scale
Mean oxygen saturation	1 week	Percentage
Flow-limitation severity	1 week	flow:drive ratio (nasal pressure airflow shape), %
Visual-Analog Scale for Sleep Quality	1 week	0-10 scale
Snoring frequency	1 week	snoring frequency (tracheal microphone), snores per hour of total sleep time
Snoring Self-Evaluation Scale	1 week	frequency, loudness, disruption, bothersome, 5-point scales
Snoring Bed-Partner Evaluation Scale	1 week	frequency, loudness, disruption, bothersome, 5-point scales
Flow-limitation frequency	1 week	breaths per hour (nasal pressure airflow shape)
"Would you keep using this medication?"	1 week	Yes/No

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States