Health Condition 1: G470- Insomnia
Conditions
Interventions
Intervention1: Clever Sleep 1: 3 capsules per day
Oral Dose
6 weeks
Control Intervention1: Not Applicable: Not Applicable
Sponsors
SleepDrops International Limited
Eligibility
Inclusion criteria
Inclusion criteria: The person who met ICSD-3 insomnia criteria and determined the following through the CleverSleep SAS tool Participants who are having moderate to severe insomnia Patient must present with normal readings when tested for LFT and eGFR Creatinine levels and Blood Pressure Participants who are willing to take CleverSleep Products for the entire duration of the study Participants who are willing to complete all surveys Participants who are willing to give samples for safety testing
Exclusion criteria
Exclusion criteria: Any other sleep disorders Excessive daytime sleepiness of unknown or untreated cause Parasomnias (example sleepwalking night terrors) and sleep-related movement disorders such as restless legs syndrome (RLS) Use of prescription sleep medications within the last 30 days Use of medications included on the exclusion checklist provided No psychiatric (including depression and anxiety) or neurological conditions History of alcohol/substance abuse Shift workers Smokers Diabetes (Type 1 and 2) Major stress event in past 3 months Deprivation index-ensuring socioeconomic consistency and in employment Participants with a child under the age of 5 in the household will be excluded Caregivers whose duties significantly disrupt nighttime sleep will be excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall improvement in sleep duration (change in Total sleep time (TST) from baseline The reduction in sleep latency as the time taken to fall asleep, compared to baseline measurements Improvement in sleep continuity (decrease in number of nighttime awakenings from baseline Improvement in time taken to return to sleep after nighttime awakenings Improvement in self-reported alertness 30 minutes after wakingTimepoint: Week 00 Week 02 Week 04 Week 06 Week 08 | — |
Secondary
| Measure | Time frame |
|---|---|
| If any adverse events (AE) or abnormal biological markers occur during period with their associated incidence and severity reported during the study periodTimepoint: Week 00 Week 02 Week 04 Week 06 Week 08 | — |
Countries
India
Contacts
Public ContactDr Anbhazagan Ramaraju
Delta Diabetic Centre
Outcome results
None listed