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

Primary Purpose

Sleep Apnea Syndromes, Cerebral Infarction

Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Trazodone
Placebo oral tablet
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea Syndromes

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • Chang Gung Memorial Hospital, Keelung

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Trazodone

Placebo

Arm Description

take trazodone 100mg hs

take placebo pill hs

Outcomes

Primary Outcome Measures

nocturnal oxygen saturation
mean and minimum oxyhemoglobin saturation (%) detected by pulse oximetry during polysomnography study
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.

Secondary Outcome Measures

Full Information

First Posted
November 10, 2019
Last Updated
April 3, 2020
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04162743
Brief Title
The Effect of Trazodone on the Severity of Obstructive Sleep Apnea in Insomnic Stroke Patients With Depression
Official Title
The Effect of Trazodone on the Severity of Obstructive Sleep Apnea in Insomnic Stroke Patients With Depression
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndromes, Cerebral Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trazodone
Arm Type
Active Comparator
Arm Description
take trazodone 100mg hs
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
take placebo pill hs
Intervention Type
Drug
Intervention Name(s)
Trazodone
Intervention Description
take trazodone 100mg before polysomnography
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Intervention Description
take placebo oral tablet before polysomnography
Primary Outcome Measure Information:
Title
nocturnal oxygen saturation
Description
mean and minimum oxyhemoglobin saturation (%) detected by pulse oximetry during polysomnography study
Time Frame
the polysomnography study night before take drug
Title
Sleep apnea severity index
Description
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.
Time Frame
the polysomnography study night before take drug

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Facility Information:
Facility Name
Chang Gung Memorial Hospital, Keelung
City
Keelung
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33625584
Citation
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.
Results Reference
derived

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

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