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

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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Key information

Conditions

Sleep Apnea Syndromes Apnea Brain Diseases Brain Infarction Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebral Infarction Cerebrovascular Disorders Dyssomnias Infarction Ischemia Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders Stroke Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chang Gung Memorial Hospital, Keelung

Keelung, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Trazodone

Drug

take trazodone 100mg before polysomnography

Placebo oral tablet

Drug

take placebo oral tablet before polysomnography

Primary outcomes

nocturnal oxygen saturation

Time frame: the polysomnography study night before take drug

mean and minimum oxyhemoglobin saturation (%) detected by pulse oximetry during polysomnography study
Sleep apnea severity index

Time frame: the polysomnography study night before take drug

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.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Nov 14, 2019
Registry last updated: Apr 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed