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NCT04162743 Clinical Trial

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

Sleep Apnea Syndromes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04162743
Other study ID # CMRPG2I0021
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date February 1, 2019
Est. completion date March 31, 2020

Study information
Verified date April 2020
Source Chang Gung Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 22
Est. completion date March 31, 2020
Est. primary completion date March 31, 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Taiwan Chang Gung Memorial Hospital, Keelung Keelung

Sponsors (1)
Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary nocturnal oxygen saturation mean and minimum oxyhemoglobin saturation (%) detected by pulse oximetry during polysomnography study the polysomnography study night before take drug
Primary Sleep apnea severity index 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. the polysomnography study night before take drug
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