Health Condition 1: - Health Condition 2: F438- Other reactions to severe stress
Conditions
Interventions
Control Intervention1: Placebo: Micro crystal cellulose
Sponsors
International Institute of Sleep Sciences
Eligibility
Inclusion criteria
Inclusion criteria: The following criteria are to be checked at the time of screening. The participant may only be included in the study if ALL the following statements are FULLFILLED: 1. With age of at least 18 years to 65 years 2. PSS score > 14 3. Have not taken any hypnotic medicines, Supplements within last 3 months. 4. Able to communicate and read in English. 5. Women of child-bearing potential (refer to appendix for definition) willing to use an adequate method of contraception to avoid pregnancy throughout the study period. 6. No Caffeine or Alcohol intake 12 hours prior to Polysomnogram study 7. Willing to provide written informed consent.
Exclusion criteria
Exclusion criteria: Participants with heart disease, sleep disorders such as OSA and PLMD, with hepatic impairment, those working in shifts, history of drug abuse and on any sedating medications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean percent change in CAP rate between Baseline and Treatment sleep studyTimepoint: Visit 3 (baseline) and Visit 11 (8 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Change in PSS, ISI, RSQ-W and PSQI score 2. Changes in other Sleep parameters such as Total Sleep time, Sleep Efficiency, Stage 3 sleep, REM duration and REM latency 3.Adverse effects Timepoint: 1. Visit 1, Visit 7 and Visit 11 next day 2. Visit 3 and Visit 11 3. All visits | — |
Countries
India
Contacts
Public ContactDr Nushafreen Irani
International Institute of Sleep Sciences
Outcome results
None listed