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

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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 31, 2020

Interventions

  • Drug: Trazodone
    • take trazodone 100mg before polysomnography
  • Drug: Placebo oral tablet
    • take placebo oral tablet before polysomnography

Arms, Groups and Cohorts

  • Active Comparator: Trazodone
    • take trazodone 100mg hs
  • Placebo Comparator: Placebo
    • take placebo pill hs

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chang Gung Memorial Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: CHEN,CHUNG YAO, doctor – Chang Gung Memorial Hospital

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