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SnoringPhase 1/2NCT03720353

Pharmacological Intervention for Symptomatic Snoring

A Phase 1/2 study testing SAS2094AH and SAS2094BH and SAS2094AL and SAS2094BL in people with Snoring, run by Brigham and Women's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 79 years
Conditions the study is for
Snoring
What is being tested?
SAS2094AH and SAS2094BH and SAS2094AL and SAS2094BL
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
27 participants
Where
1 siteUnited States
Study dates
17 Dec 2018to 10 Dec 2019
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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".

Who cannot join

  • 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:
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  • 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).
  • Thus, strictly, the study population will include patients with symptomatic habitual snoring, with or without mild OSA (i.e. AHI<5 and 5≤AHI<15). We note that studies in patients with moderate-to-severe OSA have already been performed (AHI>15), and further studies in this population are in progress. The inclusion of "mild OSA" will prevent a gap in the inclusion criteria for the investigation of the current intervention.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

Other trials in United States

About this study

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.

Read the 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.

Conditions
Snoring
Being tested
SAS2094AH and SAS2094BH, SAS2094AL and SAS2094BL, Placebo
Medical subject headings
Snoring

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SAS2094AH and SAS2094BHDrug

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

  • SAS2094AL and SAS2094BLDrug

    SAS2094AL and SAS2094BL for 10 days

  • PlaceboDrug

    Placebo for 10 days. Capsules will mimic active treatments.

Study groups in NCT03720353
Study groupRoleWhat they receive
Active HActive comparatorParticipants will take SAS2094AL and SAS2094BH for 3 days, then SAS2094AH and SAS2094BH for 7 days.
Receives: Drug: SAS2094AH and SAS2094BH
Active LActive comparatorParticipants will take SAS2094AL and SAS2094BL for 10 days
Receives: Drug: SAS2094AL and SAS2094BL
PlaceboPlacebo comparatorParticipants will take placebo for 10 days.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Snoring intensity

    mean tracheal snoring sound intensity (tracheal microphone), decibels

    Measured: 1 week

Secondary outcomes (13)

  1. Snoring frequency

    snoring frequency (tracheal microphone), snores per hour of total sleep time

    Measured: 1 week

  2. Snoring Self-Evaluation Scale

    frequency, loudness, disruption, bothersome, 5-point scales

    Measured: 1 week

  3. Snoring Bed-Partner Evaluation Scale

    frequency, loudness, disruption, bothersome, 5-point scales

    Measured: 1 week

  4. Flow-limitation frequency

    breaths per hour (nasal pressure airflow shape)

    Measured: 1 week

  5. Flow-limitation severity

    flow:drive ratio (nasal pressure airflow shape), %

    Measured: 1 week

  6. Visual-Analog Scale for Sleep Quality

    0-10 scale

    Measured: 1 week

  7. Mean oxygen saturation

    Percentage

    Measured: 1 week

  8. Stage 1 Sleep

    %Total sleep time

    Measured: 1 week

  9. Arousal index

    events per hour of total sleep time

    Measured: 1 week

  10. Visual-Analog Scale for Treatment Satisfaction

    0-10 scale

    Measured: 1 week

  11. Epworth Sleepiness Scale

    units on a scale

    Measured: 1 week

  12. Functional Outcomes of Sleep Questionnaire

    30 items, units on a scale

    Measured: 1 week

  13. "Would you keep using this medication?"

    Yes/No

    Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2018
  2. Study start17 Dec 2018
  3. Primary completion10 Dec 2019
  4. Study completion10 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03720353
Sponsor's protocol ID
2018P002094
Status last verified
Dec 2019
First submitted
24 Oct 2018
Last updated
12 Dec 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided: Data will be owned by study Sponsor Apnimed, and may be made available per request.

Publications

  • 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.

    PubMed 40471069

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SAS2094AH and SAS2094BH and SAS2094AL and SAS2094BL in people with Snoring, run by Brigham and Women's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Snoring intensity (time frame: 1 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03720353, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2019; AzTrials last refreshed its copy on 26 Oct 2026.

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