Sleep Disturbance
Conditions
Keywords
Sleep quality, Sleep latency, Insomnia symptoms
Brief summary
This study evaluates the effects of the Speed Sleep supplement on sleep quality and quantity in adults aged 18-65 years. Participants will be randomized to receive either the supplement or placebo for 4 weeks, with outcomes assessed using Fitbit sleep tracking data and questionnaires.
Interventions
DIETARY_SUPPLEMENTDietary Supplement: Speed Sleep
Six capsules taken once daily 30 minutes before bedtime.
DIETARY_SUPPLEMENTPlacebo
Six rice flour capsules taken once daily 30 minutes before bedtime.
Sponsors
Bio Nature Health
Citruslabs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female * Aged 18-65 * Experiencing issues with sleep (falling asleep, staying asleep) * Generally healthy * Willing to discontinue sleep-related supplements * Maintain consistent sleep patterns * Resides in the United States
Exclusion criteria
* Chronic medical or sleep disorders * Use of sleep medications * Hormone therapy or anticoagulants * Heavy alcohol use * Night shift workers * Pregnancy or breastfeeding * Smoking or substance abuse * Allergies to ingredients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sleep Score | Baseline and Week 4 | Assessed using Fitbit-generated sleep score reflecting overall sleep quality. Higher scores indicate better sleep quality. |
| Change in Total Sleep Time | Baseline and Week 4 | Measured using Fitbit as total time asleep during the night. |
| Change in Time Awake During Sleep Period | Baseline and Week 4 | Measured using Fitbit as total time awake during the sleep period. |
| Change in Number of Awakenings | Baseline and Week 4 | Measured using Fitbit as number of awakenings during the sleep period. |
| Change in Deep Sleep Duration | Baseline and Week 4 | Measured using Fitbit as time spent in deep sleep stages. |
| Change in REM Sleep Duration | Baseline and Week 4 | Measured using Fitbit as time spent in REM sleep stages. |
| Change in Sleep Quality Score (SQS) | Baseline, Week 1, Week 2, Week 3, Week 4 | Assessed using the validated Sleep Quality Score (SQS) questionnaire. Scores reflect subjective sleep quality, with changes over time indicating improvement or decline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sleep Latency | Baseline, Week 1, Week 2, Week 3, Week 4 | Assessed via questionnaire responses evaluating time required to fall asleep. |
| Change in Self-Reported Anxiety Levels | Baseline, Week 1, Week 2, Week 3, Week 4 | Assessed via questionnaire responses evaluating perceived anxiety related to sleep. |
| Change in Self-Reported Level of Relaxation | Baseline, Week 1, Week 2, Week 3, Week 4 | Assessed via questionnaire responses evaluating perceived relaxation before sleep. |
Countries
United States
Outcome results
None listed