Pharmacological Intervention for Symptomatic Mild Sleep Disordered Breathing

NCT04611750 | Completed Phase 2 FDA Drug

• 1 other identifier: 2020P002259
• Study Type: interventional
• Target: 53
• Locations: 2 countries
• Sites: 2

Brief 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. 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.

Conditions

Sleep Disordered Breathing

Keywords

Inspiratory flow limitation; Snoring; Mild Sleep Apnea

Outcome Measures

Primary Outcomes (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

  14 days

Secondary Outcomes (3)

• Snoring Frequency

  14 days

• Flow Limitation Frequency

  14 days

• Apnea-Hypopnea Index

  14 days

Other Outcomes (9)

• Snoring Intensity

  14 days

• Flow Limitation Severity, %

  14 days

• Hypoxic Burden

  14 days

Study Arms (2)

Active Medication (AD036)

EXPERIMENTAL

Participants will take AD036 QHS for 14 days.

Drug: AD036

Placebo Medication

PLACEBO COMPARATOR

Participants will take placebo QHS for 14 days.

Drug: Placebo

Interventions

AD036 DRUG

AD036 will be given for 14 days

Active Medication (AD036)

Placebo DRUG

Placebo will be given for 14 days

Placebo Medication

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Apnimed: collaborator

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02141, United States

Location

Monash University

Clayton, Victoria, 3168, Australia

Location

Related Publications (1)

• 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.

  PMID: 39688178 DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes; Snoring

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; 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

• Bradley A Edwards, PhD

  Monash University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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 29, 2020
• First Posted: November 2, 2020
• Study Start: December 2, 2020
• Primary Completion: January 18, 2022
• Study Completion: January 18, 2022
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); AU (1)