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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04162743

Enrollment

Registered

2019-11-14

Start date

2019-02-01

Completion date

2020-03-31

Last updated

2020-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Infarction, Sleep Apnea Syndromes

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.

Interventions

DRUGTrazodone

take trazodone 100mg before polysomnography

DRUGPlacebo oral tablet

take placebo oral tablet before polysomnography

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
nocturnal oxygen saturation	the polysomnography study night before take drug	mean and minimum oxyhemoglobin saturation (%) detected by pulse oximetry during polysomnography study
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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026