Role of Mirtazapine in Ameliorating Sleep Disordered Breathing

NCT04799782 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 100712M1F(V)
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Spinal Cord Injuries; Sleep Disordered Breathing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• AHI (Apnea/Hypopnea Index)

  One Week

Study Arms (2)

Mirtazapine

ACTIVE COMPARATOR

The drug will be taken for a one week peroid.

Drug: Mirtazapine

Placebo

PLACEBO COMPARATOR

The drug will be taken for a one week peroid.

Drug: Placebo

Interventions

Mirtazapine DRUG

15 mg dose before bed-time

Mirtazapine

Placebo DRUG

One placebo pill before bed-time

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wayne State University: lead

MeSH Terms

Conditions

Spinal Cord Injuries; Sleep Apnea Syndromes

Interventions

Mirtazapine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

* The sample size is small and the majority are males, therefore findings from this study may not be applicable to the general population * The study required heavy instrumentation which may have affected natural sleep

Results Point of Contact

• Title: Dr. Abdulghani Sankari Principal Investigator
• Organization: JOHN D DINGELL VA MEDICAL CENTER

abdulghani.sankari@va.gov

13135761000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Clinical Educator, Pulmonary/Critical Care Fellowship Program Director

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 16, 2021
• Study Start: January 1, 2017
• Primary Completion: May 18, 2019
• Study Completion: May 18, 2019
• Last Updated: June 15, 2021
• Results First Posted: April 20, 2021

Record last verified: 2021-05