The Effect of Trazodone on the Severity of Obstructive Sleep Apnea in Insomnic Stroke Patients With Depression

Chang Gung Memorial Hospital22 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Sleep Apnea Syndromes Cerebral Infarction

Interventions

TrazodoneDRUG

take trazodone 100mg before polysomnography

Placebo oral tabletDRUG

take placebo oral tablet before polysomnography

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Insomnic ischemic stroke patients with OSA and depression. Exclusion Criteria: * unclear consciousness, unstable vital sign or neurologic sign, unstable medical conditions such as delirium, active infection, evidence of overt congestive cardiac failure, liver dysfunction with ascites, thyroid disease, end-stage-renal-disease receiving dialysis. * overnight mean oxygen saturation (SaO2) nadir is ≤ 70% at baseline * take monoamine oxidase inhibitors (MAOI), any medication that may affect breathing, sleep, or muscle activity * any known allergy to trazodone * sleep disorder other than OSA (e.g., periodic leg movement syndrome, restless legs syndrome, central sleep apnea/Cheyne-Stokes respiration).

Locations (1)

Chang Gung Memorial Hospital, Keelung

Keelung, Taiwan

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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