Pharmacological Intervention for Symptomatic Snoring

NCT03720353 | Completed Phase 1 FDA Drug

• 1 other identifier: 2018P002094
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Snoring

Outcome Measures

Primary Outcomes (1)

• Snoring intensity

  mean tracheal snoring sound intensity (tracheal microphone), decibels

  1 week

Secondary Outcomes (13)

• Snoring frequency

  1 week

• Snoring Self-Evaluation Scale

  1 week

• Snoring Bed-Partner Evaluation Scale

  1 week

• Flow-limitation frequency

  1 week

• Flow-limitation severity

  1 week

Other Outcomes (4)

• Maximum Tracheal Snoring Sound Intensity

  1 week

• Visual-Analog Scales for Excessive Fatigue

  1 week

• Visual-Analog Scales for Wake-up Unrefreshed

  1 week

Study Arms (3)

Active H

ACTIVE COMPARATOR

Participants will take SAS2094AL and SAS2094BH for 3 days, then SAS2094AH and SAS2094BH for 7 days.

Drug: SAS2094AH and SAS2094BH

Active L

ACTIVE COMPARATOR

Participants will take SAS2094AL and SAS2094BL for 10 days

Drug: SAS2094AL and SAS2094BL

Placebo

PLACEBO COMPARATOR

Participants will take placebo for 10 days.

Drug: Placebo

Interventions

SAS2094AH and SAS2094BH DRUG

SAS2094AH and SAS2094BH for 7 days, preceded by SAS2094AL and SAS2094BH for 3 days.

Active H

SAS2094AL and SAS2094BL DRUG

SAS2094AL and SAS2094BL for 10 days

Active L

Placebo DRUG

Placebo for 10 days. Capsules will mimic active treatments.

Placebo

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-79 yrs
• 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".

You may not qualify if:

• Known obstructive sleep apnea (OSA, except "mild")
• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• 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.

  PMID: 40471069 DERIVED

MeSH Terms

Conditions

Snoring

Condition Hierarchy (Ancestors)

Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Scott A Sands, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: October 24, 2018
• First Posted: October 25, 2018
• Study Start: December 17, 2018
• Primary Completion: December 10, 2019
• Study Completion: December 10, 2019
• Last Updated: December 12, 2019

Record last verified: 2019-12

Locations

US (1)