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This is a randomized, 3-period, placebo-controlled, crossover study to examine the efficacy and safety of AD182 and AD504 versus placebo in patients with obstructive sleep apnea.
The study is designed to examine the efficacy and safety of AD182 to treat obstructive sleep apnea. The study is a three-period single-dose randomized crossover design in which patients will undergo overnight polysomnographic (PSG) testing with dosing of one of the following 3 treatments: AD182, AD504, or Placebo. Participants will return 1 week after their final crossover PSG for an end of study (EOS) Visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AD182 | Experimental | Oral capsule administered before bed |
|
| AD504 | Experimental | Oral capsule administered before bed |
|
| Placebo | Placebo Comparator | Oral capsule administered before bed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AD182 | Drug | Oral capsule administered before bed |
| |
| AD504 |
| Measure | Description | Time Frame |
|---|---|---|
| Apnea-Hypopnea Index (AHI, average number of events for every hour of sleep) | Apnea-Hypopnea Index, AD182 and AD504 vs placebo | 1 night (treatment duration) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruce Corser, MD | Intrepid Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intrepid research, LLC | Cincinnati | Ohio | 45245 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36734173 | Derived | Corser B, Eves E, Warren-McCormick J, Rucosky G. Effects of atomoxetine plus a hypnotic on obstructive sleep apnea severity in patients with a moderately collapsible pharyngeal airway. J Clin Sleep Med. 2023 Jun 1;19(6):1035-1042. doi: 10.5664/jcsm.10464. |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D017286 | Polysomnography |
| ID | Term |
|---|---|
| D008991 | Monitoring, Physiologic |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Drug |
Oral capsule administered before bed |
|
| Placebo | Drug | Oral capsule administered before bed |
|
| Polysomnography | Diagnostic Test | for all arms |
|
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |