Sleep Disorder
Conditions
Brief summary
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
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.
Interventions
OTHERSentra PM
Active Sentra PM and trazodone-like placebo
DRUGSentra PM and Trazodone (CoPack Kit Trazamine)
A CoPack Kit - Trazamine, consisting of the co-administration of Sentra PM and trazodone.
DRUGPlacebo trazodone and placebo Sentra PM
Trazodone-like placebo and Sentra PM-like placebo co-administered as placebo of Trazamine CoPack Kit.
DRUGTrazodone
active trazodone and sentra pm-like placebo
Sponsors
Targeted Medical Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to fall asleep | 14 days | Subjects time to fall asleep will be measure by patient response to questionnaires to determine if time improved, stayed the same or worsen. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Sleep | 14 days | — |
| Morning grogginess | 14 days | — |
| Feelings of depression | 14 days | — |
| Feelings of anxiety | 14 days | — |
| Improvement in parasympathetic activity | 14 days | Improved parasympathetic activity measured by 24 hour ECG holter moniter. |
Countries
United States
Outcome results
None listed