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

Sponsor

Chang Gung Memorial Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04162743

Collaborator

(none)

Enrollment

Location

Arms

13.9

Actual Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Apnea Syndromes Cerebral Infarction	Drug: Trazodone Drug: Placebo oral tablet	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 1, 2019

Actual Primary Completion Date :

Mar 31, 2020

Actual Study Completion Date :

Mar 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Trazodone take trazodone 100mg hs	Drug: Trazodone take trazodone 100mg before polysomnography
Placebo Comparator: Placebo take placebo pill hs	Drug: Placebo oral tablet take placebo oral tablet before polysomnography

Arm

Intervention/Treatment

Active Comparator: Trazodone

take trazodone 100mg hs

Drug: Trazodone

take trazodone 100mg before polysomnography

Placebo Comparator: Placebo

take placebo pill hs

Drug: Placebo oral tablet

take placebo oral tablet before polysomnography

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts 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).