Role of Mirtazapine in Ameliorating Sleep Disordered Breathing

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2019-05-18

Brief Summary

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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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Detailed Description

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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.

Conditions

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Spinal Cord Injuries Sleep Disordered Breathing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Mirtazapine

The drug will be taken for a one week peroid.

Group Type ACTIVE_COMPARATOR

Mirtazapine

Intervention Type DRUG

15 mg dose before bed-time

Placebo

The drug will be taken for a one week peroid.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

One placebo pill before bed-time

Interventions

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Mirtazapine

15 mg dose before bed-time

Intervention Type DRUG

Placebo

One placebo pill before bed-time

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes