Pharmacological Intervention for Symptomatic Mild Sleep Disordered Breathing
Overview
- Phase
- Phase 2
- Intervention
- AD036
- Conditions
- Sleep Disordered Breathing
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 53
- Locations
- 2
- Primary Endpoint
- Snoring Relationship Questionnaire (SRQ)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
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.
Investigators
Scott Aaron Sands
Assistant Professor of Medicine
Brigham and Women's Hospital
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •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.
Arms & Interventions
Active Medication (AD036)
Participants will take AD036 QHS for 14 days.
Intervention: AD036
Placebo Medication
Participants will take placebo QHS for 14 days.
Intervention: Placebo
Outcomes
Primary Outcomes
Snoring Relationship Questionnaire (SRQ)
Time Frame: 14 days
Self-reported impact of snoring on relationship and quality of life for patients and bedpartners, 0-20 scale, 0 lowest severity, 20 highest severity
Secondary Outcomes
- Flow Limitation Frequency(14 days)
- Snoring Frequency(14 days)
- Apnea-Hypopnea Index(14 days)