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

Phase 4

Completed

• Conditions: Sleep Apnea Syndromes; Cerebral Infarction
• Interventions: Drug: Trazodone; Drug: Placebo oral tablet

• Registration Number: NCT04162743
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-01
• Study First Submitted: 2019-11-10
• Study First Submitted QC: 2019-11-13
• Study First Posted: 2019-11-14
• Primary Completion: 2020-03-31
• Study Completion: 2020-03-31
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-03
• Last Update Posted: 2020-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Trazodone	Trazodone	take trazodone 100mg hs
Placebo	Placebo oral tablet	take placebo pill hs

Primary Outcome Measures

Name	Time	Method
Sleep apnea severity index	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.
nocturnal oxygen saturation	the polysomnography study night before take drug	mean and minimum oxyhemoglobin saturation (%) detected by pulse oximetry during polysomnography study

Trial Locations

Locations (1)

Chang Gung Memorial Hospital, Keelung; 🇨🇳 Keelung, Taiwan