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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04162743
Recruitment Status : Completed
First Posted : November 14, 2019
Last Update Posted : April 6, 2020
Sponsor:
Information provided by (Responsible Party):
CHEN,CHUNG YAO, Chang Gung Memorial Hospital

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

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Study Type : Interventional  (Clinical Trial)
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 : February 1, 2019
Actual Primary Completion Date : March 31, 2020
Actual Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

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




Primary Outcome Measures :
  1. nocturnal oxygen saturation [ Time Frame: the polysomnography study night before take drug ]
    mean and minimum oxyhemoglobin saturation (%) detected by pulse oximetry during polysomnography study

  2. Sleep apnea severity index [ Time Frame: 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.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04162743


Locations
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Taiwan
Chang Gung Memorial Hospital, Keelung
Keelung, Taiwan
Sponsors and Collaborators
Chang Gung Memorial Hospital
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Responsible Party: CHEN,CHUNG YAO, doctor, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT04162743    
Other Study ID Numbers: CMRPG2I0021
First Posted: November 14, 2019    Key Record Dates
Last Update Posted: April 6, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Cerebral Infarction
Infarction
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Ischemia
Pathologic Processes
Necrosis
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Stroke
Vascular Diseases
Cardiovascular Diseases
Trazodone
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors