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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
27
SAS2094AH and SAS2094BH for 7 days, preceded by SAS2094AL and SAS2094BH for 3 days.
SAS2094AL and SAS2094BL for 10 days
Placebo for 10 days. Capsules will mimic active treatments.
Brigham and Women's Hospital
Boston, Massachusetts, United States
Snoring intensity
mean tracheal snoring sound intensity (tracheal microphone), decibels
Time frame: 1 week
Snoring frequency
snoring frequency (tracheal microphone), snores per hour of total sleep time
Time frame: 1 week
Snoring Self-Evaluation Scale
frequency, loudness, disruption, bothersome, 5-point scales
Time frame: 1 week
Snoring Bed-Partner Evaluation Scale
frequency, loudness, disruption, bothersome, 5-point scales
Time frame: 1 week
Flow-limitation frequency
breaths per hour (nasal pressure airflow shape)
Time frame: 1 week
Flow-limitation severity
flow:drive ratio (nasal pressure airflow shape), %
Time frame: 1 week
Visual-Analog Scale for Sleep Quality
0-10 scale
Time frame: 1 week
Mean oxygen saturation
Percentage
Time frame: 1 week
Stage 1 Sleep
%Total sleep time
Time frame: 1 week
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Arousal index
events per hour of total sleep time
Time frame: 1 week
Visual-Analog Scale for Treatment Satisfaction
0-10 scale
Time frame: 1 week
Epworth Sleepiness Scale
units on a scale
Time frame: 1 week
Functional Outcomes of Sleep Questionnaire
30 items, units on a scale
Time frame: 1 week
"Would you keep using this medication?"
Yes/No
Time frame: 1 week