Pharmacological Intervention for Symptomatic Mild Sleep Disordered Breathing
Completed · Phase 2 · Has a placebo group
Conditions studied: Sleep Disordered Breathing
In brief
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.
Key facts
- Study ID
- NCT04611750
- Run by
- Brigham and Women's Hospital
- People needed
- 53
- Starts
- 2020-12-02
- Expected to finish
- 2022-01-18
- Last updated by the study team
- 2022-03-02
Who can join
Age: 25 and older, up to 70. Sex: any. Healthy volunteers: accepted.
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.
- 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
Where it is running
- Brigham and Women's Hospital — Boston, Massachusetts, United States
- Monash University — Clayton, Victoria, Australia
Full record on ClinicalTrials.gov
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