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.

Study Overview

• Status: Completed
• Conditions: Sleep Disordered Breathing; Spinal Cord Injuries
• Intervention / Treatment: Drug: Mirtazapine; Drug: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mirtazapine; The drug will be taken for a one week peroid.	Drug: Mirtazapine; 15 mg dose before bed-time
Placebo Comparator: Placebo; The drug will be taken for a one week peroid.	Drug: Placebo; One placebo pill before bed-time

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CO2 Reserve (Delta-PETCO2-AT)	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.	One Week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AHI (Apnea/Hypopnea Index)	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.	One Week

Collaborators and Investigators

• Sponsor: Wayne State University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): May 18, 2019
• Study Completion (Actual): May 18, 2019

Study Registration Dates

• First Submitted: March 11, 2021
• First Submitted That Met QC Criteria: March 11, 2021
• First Posted (Actual): March 16, 2021

Study Record Updates

• Last Update Posted (Actual): June 15, 2021
• Last Update Submitted That Met QC Criteria: May 21, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Sleep Apnea Syndromes; Respiratory Aspiration; Spinal Cord Injuries; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Antidepressive Agents; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Anti-Anxiety Agents; Serotonin 5-HT3 Receptor Antagonists; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Adrenergic alpha-Antagonists; Adrenergic alpha-2 Receptor Antagonists; Mirtazapine
• Other Study ID Numbers: 100712M1F(V)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes