A Phase 4 interventional study of Trazodone and Placebo oral tablet in Sleep Apnea Syndromes and Cerebral Infarction, sponsored by Chang Gung Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2020-04-06.
Sponsored by Chang Gung Memorial Hospital · Phase 4, Interventional, and Treatment
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.
2,183 studies on the registry are indexed under Sleep Apnea Syndromes; 284 are open to participants now.
This study's enrollment of 22 is below the median of 53 across 1,400 interventional studies indexed under Sleep Apnea Syndromes.
Browse Sleep Apnea Syndromes studies →Chang Gung Memorial Hospital is the lead sponsor of 1,091 studies on the registry; 238 are open to participants now.
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Exclusion Criteria:
take trazodone 100mg hs
Drug: Trazodone
take placebo pill hs
Drug: Placebo oral tablet
take trazodone 100mg before polysomnography
take placebo oral tablet before polysomnography
nocturnal oxygen saturation
mean and minimum oxyhemoglobin saturation (%) detected by pulse oximetry during polysomnography study
Time frame: 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.
Time frame: the polysomnography study night before take drug
Plan to share: No
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Trazodone
Chang Gung Memorial Hospital →