A Double-blind Placebo Controlled Trial of Sentra PM, a Medical Food

Study Overview
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Brief Summary
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This is a double blind placebo controlled study of one hundred and four subjects which will be randomized for treatment with Sentra PM alone, Sentra PM with trazadone, trazadone alone and placebo alone. Twenty -six subjects will be randomly placed in one of the four groups. Each of the one hundred and four subjects will undergo baseline examination to include a sleep study questionnaires and 24- hour electrocardiographic recording. The one hundred and four subjects will then be randomly placed in one of the four groups.

Detailed Description
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Sentra PM can induce restorative sleep compared to placebo, and as good as a sleep drug (trazadone) in subjects experiencing non-restorative sleep. Sentra PM taken with trazadone works better than either product alone. Twenty-six subjects will be randomized to a two week ingestion of Sentra PM at bedtime, twenty-six subjects will be randomized to a two week ingestion of trazadone at bedtime, twenty-six subjects will be randomized to a two week ingestion of Sentra PM with trazadone at bedtime and twenty -six subjects will be randomized to a two week ingestion of placebo at bedtime. Each morning after ingestion of either active product or placebo, the subject will fill out sleep questionnaires. On the fourteenth day of ingestion, a repeat 24-Hour ECG examination will be performed on all one hundred and four subjects and each subject will give a second blood sample for analysis. On the morning of the 14th day of ingestion the final sleep questionnaires will be completed.

Official Title
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Sentra PM (a Medical Food) and Trazadone in the Management of Sleep Disorders

Conditions
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Sleep Disorder

Intervention / Treatment
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* Drug: Trazodone
* Other: Sentra PM
* Drug: Sentra PM and Trazodone (CoPack Kit Trazamine)
* Drug: Placebo trazodone and placebo Sentra PM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females over the age of 18 and below age 65. Patients with a history of a sleep disturbance with non-restorative sleep defined by perceived increase in sleep latency or morning/daytime grogginess. Exclusion Criteria: Subjects who have previously taken GABAdone, SentraPM or trazadone. Subjects who are currently taking tricyclic anti-depressants. Any blood chemistry anomalies the investigator finds that may put the patient at risk or invalidate study results. Pregnant or lactating females. Subjects with implanted pacemakers or other implanted electrical devices

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active trazodone and placebo<br>trazodone 50mg with Sentra PM-like placebo | Drug: Trazodone<br>* active trazodone and sentra pm-like placebo<br>|
| Active Comparator: placebo and active Sentra PM<br>Trazodone-like placebo and Sentra PM | Other: Sentra PM<br>* Active Sentra PM and trazodone-like placebo<br>|
| Active Comparator: Sentra PM and trazodone<br>Active Sentra PM and active trazodone | Drug: Sentra PM and Trazodone (CoPack Kit Trazamine)<br>* A CoPack Kit - Trazamine, consisting of the co-administration of Sentra PM and trazodone.<br>|
| Placebo Comparator: placebo trazodone and placebo Sentra PM<br>trazadone-like placebo and Sentra PM-like placebo | Drug: Placebo trazodone and placebo Sentra PM<br>* Trazodone-like placebo and Sentra PM-like placebo co-administered as placebo of Trazamine CoPack Kit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to fall asleep | Subjects time to fall asleep will be measure by patient response to questionnaires to determine if time improved, stayed the same or worsen. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Sleep |  | 14 days | 
| Morning grogginess |  | 14 days | 
| Feelings of depression |  | 14 days | 
| Feelings of anxiety |  | 14 days | 
| Improvement in parasympathetic activity | Improved parasympathetic activity measured by 24 hour ECG holter moniter. | 14 days |