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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mirtazapine | Active Comparator | The drug will be taken for a one week peroid. |
|
| Placebo | Placebo Comparator | The drug will be taken for a one week peroid. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirtazapine | Drug | 15 mg dose before bed-time |
| |
| Placebo |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Of 150 available, 18 participants were enrolled. Of the 18 enrolled, 15 started the study protocol. Of the 15 that started the study protocol, 10 completed the study and had their results analyzed.
Participants were recruited to the primary site at John D. Dingell VA Medical Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo->Mirtazapine | Participants first received a placebo taken once daily for one week. After a washout period of one week, the participants then received mirtazapine taken once daily (15 mg) for one week. |
| FG001 | Mirtazapine->Placebo | Participants first received mirtazapine taken once daily (15 mg) for one week. After a washout period of one week, the participants then received a placebo taken once daily for one week. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Washout |
| |||||||||||||
| Second Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Participants who were randomized to receive either Mirtazapine (15 mg) or Placebo tablet |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Only 10 of the 15 enrolled participants finished both medication arms (placebo, mirtazapine) and were used in the final analysis. | Posted | Mean | Standard Deviation | mmHg | One Week |
|
Adverse event data were collected during the one-week interventions during which the participants were taking Mirtazapine or placebo
Of the 15 participants who started the study protocol, 13 received Mirtazapine and 12 received a placebo due to participant withdrawal and physician removal.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mirtazapine | The drug will be taken for a one week peroid. Mirtazapine: 15 mg dose before bed-time |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal Thoughts | Psychiatric disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Muscle Weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Abdulghani Sankari Principal Investigator | JOHN D DINGELL VA MEDICAL CENTER | 13135761000 | 63105 | abdulghani.sankari@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 14, 2021 | Apr 14, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 14, 2021 | Apr 14, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D000078785 | Mirtazapine |
| ID | Term |
|---|---|
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
One placebo pill before bed-time |
|
| One Week |
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| NOT COMPLETED |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Placebo |
The drug will be taken for a one week peroid. Placebo: One placebo pill before bed-time |
|
|
|
| Secondary | 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. | Only 10 of the 15 enrolled participants finished both medication arms (placebo, mirtazapine) and were used in the final analysis. | Posted | Mean | Standard Deviation | Events/Hour | One Week |
|
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 1 |
| 13 |
| EG001 | Placebo | The drug will be taken for a one week peroid. Placebo: One placebo pill before bed-time | 0 | 12 | 1 | 12 | 0 | 12 |
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| D014947 | Wounds and Injuries |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |