Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
27 participants
INTERVENTIONAL
2018-12-17
2019-12-10
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Active H
Participants will take SAS2094AL and SAS2094BH for 3 days, then SAS2094AH and SAS2094BH for 7 days.
SAS2094AH and SAS2094BH
SAS2094AH and SAS2094BH for 7 days, preceded by SAS2094AL and SAS2094BH for 3 days.
Active L
Participants will take SAS2094AL and SAS2094BL for 10 days
SAS2094AL and SAS2094BL
SAS2094AL and SAS2094BL for 10 days
Placebo
Participants will take placebo for 10 days.
Placebo
Placebo for 10 days. Capsules will mimic active treatments.
Interventions
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SAS2094AH and SAS2094BH
SAS2094AH and SAS2094BH for 7 days, preceded by SAS2094AL and SAS2094BH for 3 days.
SAS2094AL and SAS2094BL
SAS2094AL and SAS2094BL for 10 days
Placebo
Placebo for 10 days. Capsules will mimic active treatments.
Eligibility Criteria
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Inclusion Criteria
* Self-reported habitual snoring ("most of the time" or "all of the time" on Snoring Self-Evaluation Scale)
* Sleep-related symptoms defined by any of the following\*:
* Visual-Analog Scale for Sleep Quality ≤7/10 ("reduced sleep quality")
* Epworth Sleepiness Scale ≥10 ("excessive daytime sleepiness")
* Functional Outcomes of Sleep Questionnaire \<18 ("reduced sleep-related quality of life").
* Presence of a bed-partner who is able to provide feedback to the participant on snoring (Snoring Bed-Partner Evaluation Scale)
* The intention of these criteria is to enable participants with a broad range of possible snoring symptoms to be included. We note that the Visual-Analog Scale for Sleep Quality is, on average, approximately 7/10 in patients with sleep apnea; thus, we consider a value at or below 7 to indicate "reduced sleep quality".
Exclusion Criteria
* Current treatment for OSA or snoring (continuous positive airway pressure, oral appliances, supplemental oxygen)
* Use of medications expected to stimulate or depress respiration (including opioids, barbiturates, acetazolamide, doxapram, almitrine, theophylline, 4-hydroxybutanoic acid).
* Use of similar medications to the study drugs.
* Conditions likely to affect obstructive sleep apnea physiology: neuromuscular disease or other major neurological disorder, heart failure (also below), or any other unstable major medical condition.
* Respiratory disorders other than sleep disordered breathing:
o chronic hypoventilation/hypoxemia (awake oxygen saturation \< 92% by oximetry) due to chronic obstructive pulmonary disease or other respiratory conditions.
* Other sleep disorders: periodic limb movements (periodic limb movement arousal index \> 10/hr), narcolepsy, or parasomnias.
* Contraindications to the study drugs, including:
* clinically-significant kidney disorders (eGFR\<60 ml/min/1.73m2)
* clinically-significant liver disorders
* clinically-significant cardiovascular conditions
* severe hypertension (systolic blood pressure above 180 mmHg or diastolic below 110 mmHg measured at baseline)
* cardiomyopathy (left ventricular ejection fraction, LVEF\<50%) or heart failure
* advanced atherosclerosis
* history of cerebrovascular events
* history of cardiac arrhythmias e.g., atrial fibrillation, QT prolongation
* other serious cardiac conditions
* myasthenia gravis
* pregnancy/breast-feeding
We will not make new measurements of eGFR, LVEF or document their presence/absence for each participant.
Criteria for Randomization
After the baseline visit, the following criteria need to be met to continue participation:
* Participants with AHI≥15 events/hr (moderate-to-severe OSA, hypopneas based on a 30% reduction in flow, accompanied by either a 3% oxygen desaturation or scored EEG-arousal) on the baseline study night, will not continue further participation after the baseline visit.
* Participants must exhibit evidence of snoring during the baseline sleep study for further participation (mean tracheal sound intensity, Leq, exceeding 80 dB); the precise cutoff will be pilot tested in ongoing protocols (where snoring is routinely measured).
18 Years
79 Years
ALL
No
Sponsors
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Brigham and Women's Hospital
OTHER
Responsible Party
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Scott Aaron Sands
Assistant Professor of Medicine
Principal Investigators
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Scott A Sands, PhD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
Countries
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References
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Calianese N, Hess LB, Vena D, Konefal R, Mann DL, Taranto-Montemurro L, Bertisch SM, Sofer T, Azarbarzin A, Gell LK, Sands SA. Atomoxetine plus oxybutynin for symptomatic snoring and airflow limitation in individuals without moderate-to-severe obstructive sleep apnea. J Clin Sleep Med. 2025 Sep 1;21(9):1579-1590. doi: 10.5664/jcsm.11760.
Other Identifiers
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2018P002094
Identifier Type: -
Identifier Source: org_study_id