Pharmacological Intervention for Symptomatic Snoring
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Snoring intensity
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 79 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Active H
Participants will take SAS2094AL and SAS2094BH for 3 days, then SAS2094AH and SAS2094BH for 7 days.
Intervention: SAS2094AH and SAS2094BH (Drug)
Active L
Participants will take SAS2094AL and SAS2094BL for 10 days
Intervention: SAS2094AL and SAS2094BL (Drug)
Placebo
Participants will take placebo for 10 days.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Snoring intensity
Time Frame: 1 week
mean tracheal snoring sound intensity (tracheal microphone), decibels
Secondary Outcomes
- Stage 1 Sleep(1 week)
- Arousal index(1 week)
- Visual-Analog Scale for Treatment Satisfaction(1 week)
- Epworth Sleepiness Scale(1 week)
- Visual-Analog Scale for Sleep Quality(1 week)
- Flow-limitation severity(1 week)
- Mean oxygen saturation(1 week)
- Snoring frequency(1 week)
- Snoring Self-Evaluation Scale(1 week)
- Snoring Bed-Partner Evaluation Scale(1 week)
- Flow-limitation frequency(1 week)
- Functional Outcomes of Sleep Questionnaire(1 week)
- "Would you keep using this medication?"(1 week)
Investigators
Scott Aaron Sands
Assistant Professor of Medicine
Brigham and Women's Hospital