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

Chang Gung Medical Foundation

Status and phase: Completed; Phase 4

Conditions: Cerebral Infarction; Sleep Apnea Syndromes

Treatments: Drug: Placebo oral tablet; Drug: Trazodone

Study type: Interventional

Funder types: Other

Identifiers

NCT04162743

CMRPG2I0021

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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22 participants in 2 patient groups, including a placebo group

Trazodone

Active Comparator group

Description:

take trazodone 100mg hs

Treatment:

Drug: Trazodone

Placebo

Placebo Comparator group

Description:

take placebo pill hs

Treatment:

Drug: Placebo oral tablet