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

NCT ID: NCT04162743

Last Updated: 2020-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2020-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sleep Apnea Syndromes Cerebral Infarction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Trazodone

take trazodone 100mg hs

Group Type ACTIVE_COMPARATOR

Trazodone

Intervention Type DRUG

take trazodone 100mg before polysomnography

Placebo

take placebo pill hs

Group Type PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type DRUG

take placebo oral tablet before polysomnography

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Trazodone

take trazodone 100mg before polysomnography

Intervention Type DRUG

Placebo oral tablet

take placebo oral tablet before polysomnography

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

CHEN,CHUNG YAO

doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chang Gung Memorial Hospital, Keelung

Keelung, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

References

Explore related publications, articles, or registry entries linked to this study.

Chen CY, Chen CL, Yu CC. Trazodone improves obstructive sleep apnea after ischemic stroke: a randomized, double-blind, placebo-controlled, crossover pilot study. J Neurol. 2021 Aug;268(8):2951-2960. doi: 10.1007/s00415-021-10480-2. Epub 2021 Feb 24.

Reference Type DERIVED
PMID: 33625584 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CMRPG2I0021

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Melatonin in Acute Stroke
NCT03843008 WITHDRAWN NA