Role of Mirtazapine in Ameliorating Sleep Disordered Breathing

The purpose of this study is to look at the effect of using Mirtazapine to target a specific pathway in the body, that relies on a natural chemical the body produces called 'serotonin', in patients with spinal cord injury (SCI) and non-injured persons during sleep. During this part of the study participants will be asked to take Mirtazapine (15mg per day) and a placebo in a random fashion, each for a one week period (drug period) of time followed by one week without drugs (washout period). The drugs will not be taken all at the same time, but each will be taken separately for one weeks followed by a night study to look at the effect the Mirtazapine/placebo pill has on the way the body responds during sleep.

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Key information

Conditions

Spinal Cord Injuries Apnea Central Nervous System Diseases Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disordered Breathing Sleep Disorders, Intrinsic Sleep Wake Disorders Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

Randomized placebo controlled cross-over study. Each subject will be studied on two separate occasions: (1) Mirtazapine vs. placebo for one week; the participants will be blinded to whether they are taking Mirtazapine or placebo. After the one week treatment a sleep study will be repeated. Mirtazapine will be given at 15 mg dose before bed-time. (2) Cross over medication for one week will be followed by a second sleep study.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adults with SCI (>6months after spinal cord injury) at the T6 level/above
Non-injured adults

Exclusion criteria

Pregnant and lactating females
Heart failure, vascular disease, or stroke
Advanced chronic obstructive pulmonary disease (COPD), liver disease, and chronic kidney disease
BMI >38 kg/m2
Mechanical ventilation dependence

Treatment and study plan

mirtazapine

Drug

15 mg dose before bed-time

Placebo

Drug

One placebo pill before bed-time

Primary outcomes

CO2 Reserve (Delta-PETCO2-AT)

Time frame: One Week

Randomized placebo-controlled cross-over study. Each subject was studied on two separate occasions: (1) Mirtazapine vs. placebo for one week; After the one-week treatment a physiological sleep study was performed to determine the CO2 reserve (Delta-PETCO2-AT) and hypocapnic apneic threshold. (2) Cross over medication for one week was followed by a second physiological sleep study to determine the CO2 reserve (Delta-PETCO2-AT) and hypocapnic apneic threshold.

Secondary outcomes

AHI (Apnea/Hypopnea Index)

Time frame: One Week

AHI is an index that measures the severity of sleep apnea and is calculated by dividing the total number of apneas and hypopneas by the number of hours of sleep. Randomized placebo-controlled cross-over study. Each subject was studied on two separate occasions: (1) Mirtazapine vs. placebo for one week; After the one-week treatment a polysomnogram (PSG) study was performed to determine the AHI. (2) Cross over medication for one week was followed by a second PSG to determine the AHI.

Sponsors and collaborators

Lead sponsor

Wayne State University

Other

Registry information

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2019
First posted: Mar 16, 2021
Registry last updated: Jun 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed