Psychophysiological insomnia
Conditions
Interventions
Divide Yokukansan`s daily dosage of 7.5g into three doses and administer before or between meals for 7 consecutive days.
Sponsors
The Jikei university school of medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who have been diagnosed with psychophysiological insomnia according to the diagnostic criteria outlined by Internationl Classification of Sleep Disorder II (ICSD II). 2) Patients who report insomnia of greater than 4 weeks of duration. 3) Age specification: Patients who are between ages 20-65 (at the time of signing informed consent). 4) Patients who have signed consent to participate in this research. 5) There is no gender specification.
Exclusion criteria
Exclusion criteria: 1) Patients with insomnia that accompany schizophrenia and manic-depressive psychosis. 2) Patients with pharmacologically-induced insomnia, including anti-Parkinson`s, anti-hypertensive and steroid-type drugs. 3) Patients with insomnia due to serious psychosomatic disorders. 4) Patients who have sleep-related respiratory disorders, Periodic Limb Movement Disorder and Restless Leg Syndrome. 5) Patients who have taken Kampo medicine within the last 4 weeks. 6) Patients who have taken psychotropic drugs, anti-histamine drugs, or melatonin, etc. within the last 4 weeks. 7) Patients who have participated in research with other interventions. 8) Patients who are otherwise classified as unfit by the attending physicians for the research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Perform PSG before and after administering Yokukansan for seven consecutive days. PSG data will then be investigated with R&K and CAP(Cyclic alternating pattern). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Acti-graph (device to measure activity level) : Device is worn throughout the entire duration of the test, from 3 days prior to performing PSG until the end of test. 2. Sleep diary: Recorded 3 days prior to performing PSG until the end of test. 3. PSQ (Pittsburgh Sleep Quality Index): Recorded before PSG is performed. 4. PVT (psychomotor vigilance task): Performed after PSG testing (1. immediately upon waking, 2. at 9am, 3. at 11am) 5. VAS (visual analog scale): Recorded after PSG is performed (1. immediately upon waking, 2. at 9am, 3. at 11am) 6. SSS (Standford Sleepiness Scale): Raecorded after PSG is performed (1. immediately upon waking, 2. 9:00AM, 3. 11:00AM) 7. SAM (Space Aeromedicine Fatigue Checklist): Recorded after PSG is performed (1. immediately upon waking, 2. 9:00AM, 3. 11:00AM) 8. SMH (St. Mary`s Hospital Sleep Questionnaire): Recorded after PSG is performed (1. 8:00AM) | — |
Countries
Japan
Contacts
Public ContactMotohiro Ozone
The Jikei university school of medicine Department of Psychiatry
Outcome results
None listed