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Sleep Disordered BreathingPhase 2NCT04611750

Pharmacological Intervention for Symptomatic Mild Sleep Disordered Breathing

A Phase 2 study testing AD036 in people with Sleep Disordered Breathing, run by Brigham and Women's Hospital at 2 sites in 2 countries.

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 for mild symptomatic obstructive sleep disordered breathing (SDB) in the form of loud habitual snoring, inspiratory flow limitation (i.e. upper airway resistance syndrome), or mild sleep apnea. Read more about this study

Who is it for?
Ages 25 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Sleep Disordered Breathing
What is being tested?
AD036
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
53 participants
Where
2 sitesin 2 countries
Study dates
2 Dec 2020to 18 Jan 2022
Phase
Phase 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 25 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Between 25 to 70 years of age, inclusive
  • SRQ at screening ≥ 4 (at least mild impact of snoring)
  • ESS at screening ≤ 12 (absence of sleepiness)
  • BMI between 18.5 and 40 kg/m2, inclusive.
  • Use of specified contraceptive methods if appropriate
  • AHI ≥5-10, or AHI 0-<5 if either:
Show all 10Show fewer
  • Snoring frequency (100dB snoring for >10% of sleep) by tracheal microphone, or
  • Flow limitation frequency (>50% obstruction for >10% of sleep).
  • PGI-S that improves by at least 1 point during AD036 run-in period
  • PGI-S that improves by at least 1 point during AD036 run-in period.

Who cannot join

  • Participants are excluded from the study if any of the following criteria apply:
  • History of narcolepsy
  • Clinically significant craniofacial malformation
  • Clinically significant cardiac disease (e.g., rhythm disturbances, coronary artery disease or cardiac failure) or hypertension requiring more than 2 medications for control.
  • Clinically significant neurological disorder, including epilepsy/convulsions.
  • History of schizophrenia, schizoaffective disorder or bipolar disorder
Show all 53Show fewer
  • History of attempted suicide or suicidal ideation within 1 year prior to screening, or current suicidal ideation.
  • History of clinically significant constipation, gastric retention, or urinary retention.
  • Positive screen for drugs of abuse or substance use disorder
  • A significant illness or infection requiring medical treatment in the past 30 days.
  • Clinically significant cognitive dysfunction.
  • Untreated narrow angle glaucoma.
  • Women who are pregnant or nursing.
  • History of using oral or nasal devices for the treatment of OSA or snoring; may enroll as long as the devices are not used during participation in the study.
  • History of using devices to affect participant sleeping position for the treatment of OSA or snoring, e.g. to discourage supine sleeping position; may enroll as long as the devices are not used during participation in the study.
  • History of oxygen therapy (last 12 months).
  • Use of medications from the list of disallowed concomitant medications during study participation.
  • MAOIs or other drugs that affect monoamine concentrations (e.g., rasagiline) [MAOIs are contraindicated for use with atomoxetine]
  • Selective Serotonin Reuptake Inhibitors (e.g., paroxetine)
  • Selective Norepinephrine Reuptake Inhibitors (e.g., duloxetine)
  • Norepinephrine Reuptake Inhibitors (e.g., reboxetine)
  • Alpha-1 antagonists (e.g., tamsulosin)
  • Tricyclic antidepressants (e.g., desipramine)
  • Centrally acting antihypertensives (e.g. clonidine, alpha-methyl-DOPA)
  • CYP2D6 inhibitors
  • Strong CYP3A4 inhibitors (e.g., ketoconazole)
  • Benzodiazepines and other anxiolytics or sedatives
  • Nonbenzodiazepine hypnotics
  • Opioids
  • Muscle relaxants
  • Pressor agents
  • Drugs with clinically significant cardiac QT-interval prolonging effects
  • Drugs known to lower seizure threshold (e.g., chloroquine)
  • Amphetamines
  • Antiepileptics
  • Antiemetics
  • Modafinil or armodafinil
  • Beta2 agonists, (e.g., albuterol)
  • Antipsychotics
  • Anticholinergics and anticholinesterase inhibitors, including drugs with substantial anticholinergic side effects, (e.g., first generation antihistamines)
  • Sedating antihistamines
  • Pseudoephedrine, phenylephrine, oxymetazoline
  • Nicotine replacement products
  • Most drugs for Parkinson's, Alzheimer's, Huntington's, Amyotrophic Lateral Sclerosis, or drugs for other neurodegenerative diseases
  • Treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors, strong cytochrome P450 2D6 (CYP2D6) inhibitors, or monoamine oxidase inhibitors (MAOI) within 14 days of the start of treatment, or concomitant with treatment.
  • Use of another investigational agent within 30 days or 5 half-lives prior to dosing, whichever is longer.
  • <5 hours typical sleep duration.
  • Smoking more than 10 cigarettes or 2 cigars per day.
  • Unwilling to use specified contraception.
  • Unwilling to limit alcohol consumption to no greater than 2 units/day or less for men, or 1 unit/day for women, not to be consumed within 3 hours of bedtime.
  • Unwilling to limit caffeinated beverage intake (e.g., coffee, cola, tea) to 400 mg/day or less of caffeine (approximately 4 cups of coffee); caffeine not to be used within 3 hours of bedtime.
  • Any condition that in the investigator's opinion would present an unreasonable risk to the participant, or which would interfere with their participation in the study or confound study interpretation.
  • Participant considered by the investigator, for any reason, an unsuitable candidate to receive AD036 or unable or unlikely to understand or comply with the dosing schedule or study evaluations.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02141

Other trials in United States

Australia1 site

  • Monash University

    Clayton, Victoria, 3168

Other trials in Australia

About this study

Currently, there is no pharmacological intervention for mild symptomatic obstructive sleep disordered breathing (SDB) in the form of loud habitual snoring, inspiratory flow limitation (i.e. upper airway resistance syndrome), or mild sleep apnea. Here the investigators study the effect on SDB of stimulating pharyngeal muscles during sleep with AD036. The key hypothesis of the study is that AD036 is superior to placebo on self-reported and objective measures of SDB severity.

Read the detailed description

This is a randomized placebo-controlled 2-period crossover study. Each crossover period will consist of 14 days of QHS dosing of either AD036 or placebo, with a washout period of 7 days between each period.

Polysomnography will be performed at screening (baseline) and on the last dosing day of each of the two crossover dosing period.

The trial will enroll participants until a total of 24 responders are randomized into the crossover portion of the study.

Being tested
AD036, Placebo
Keywords
Inspiratory flow limitation, Snoring, Mild Sleep Apnea
Medical subject headings
Sleep Apnea Syndromes, Snoring

What participants receive

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

  • AD036Drug

    AD036 will be given for 14 days

  • PlaceboDrug

    Placebo will be given for 14 days

Study groups in NCT04611750
Study groupRoleWhat they receive
Active Medication (AD036)ExperimentalParticipants will take AD036 QHS for 14 days.
Receives: Drug: AD036
Placebo MedicationPlacebo comparatorParticipants will take placebo QHS for 14 days.
Receives: Drug: Placebo

What is being measured

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

  1. Snoring Relationship Questionnaire (SRQ)

    Self-reported impact of snoring on relationship and quality of life for patients and bedpartners, 0-20 scale, 0 lowest severity, 20 highest severity

    Measured: 14 days

Secondary outcomes (3)

  1. Snoring Frequency

    Snoring frequency, % breaths during sleep >100dB by tracheal microphone

    Measured: 14 days

  2. Flow Limitation Frequency

    Flow limitation frequency, % breaths during sleep >50% obstructed per airflow shape (Mann D et al ERJ)

    Measured: 14 days

  3. Apnea-Hypopnea Index

    Apnea-Hypopnea Index, events/hr (hypopneas per 4% desaturation)

    Measured: 14 days

Timeline

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

  1. First posted2 Nov 2020
  2. Study start2 Dec 2020
  3. Primary completion18 Jan 2022
  4. Study completion18 Jan 2022

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04611750
Sponsor's protocol ID
2020P002259
Status last verified
Feb 2022
First submitted
29 Oct 2020
Last updated
2 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: We plan not to share data

Publications

  • Hynes DJ, Mann DL, Landry SA, Joosten SA, Edwards BA, Hamilton GS. Night-to-night variability in obstructive sleep apnea severity, the physiological endotypes, and the frequency of flow limitation. Sleep. 2025 Apr 11;48(4):zsae295. doi: 10.1093/sleep/zsae295.

    PubMed 39688178

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AD036 in people with Sleep Disordered Breathing, run by Brigham and Women's Hospital at 2 sites in 2 countries.

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 10 inclusion and 53 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 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Australia. 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 phase mean?

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 Relationship Questionnaire (SRQ) (time frame: 14 days). 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 NCT04611750, 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 2 Mar 2022.

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