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The investigators hypothesize that trazodone does not worse nocturnal oxygen saturation in insomnic ischemic stroke patients with obstructive sleep apnea (OSA) and depression and has beneficial effect in selected stroke patients with low arousal threshold phenotype OSA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trazodone | Active Comparator | take trazodone 100mg hs |
|
| Placebo | Placebo Comparator | take placebo pill hs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trazodone | Drug | take trazodone 100mg before polysomnography |
| |
| Measure | Description | Time Frame |
|---|---|---|
| nocturnal oxygen saturation | mean and minimum oxyhemoglobin saturation (%) detected by pulse oximetry during polysomnography study | the polysomnography study night before take drug |
| Sleep apnea severity index | apnea-hypopnea index, desaturation index according to The American Academy of Sleep Medicine (AASM) scoring manual version 2.0.3: Obstructive apnea: no airflow >= 10 s with respiratory effort (per hour of time); central apnea: no airflow without respiratory effort (per hour of time). Hypopnea: airflow decrease >30% lasting >= 10 s, followed by either oxygen desaturation > 3% or EEG arousal (per hour of time). The desaturation index: number of desaturations per hour of time. | the polysomnography study night before take drug |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital, Keelung | Keelung | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33625584 | Derived | Chen CY, Chen CL, Yu CC. Trazodone improves obstructive sleep apnea after ischemic stroke: a randomized, double-blind, placebo-controlled, crossover pilot study. J Neurol. 2021 Aug;268(8):2951-2960. doi: 10.1007/s00415-021-10480-2. Epub 2021 Feb 24. |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D002544 | Cerebral Infarction |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| ID | Term |
|---|---|
| D014196 | Trazodone |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011728 | Pyridones |
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| Placebo oral tablet |
| Drug |
take placebo oral tablet before polysomnography |
|
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D020520 | Brain Infarction |
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D020521 | Stroke |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D011725 |
| Pyridines |