An FDA-registered Phase 2 clinical trial, published and peer-reviewed

Study design

• Design: double-blind, placebo-controlled, randomized crossover study — each participant served as their own control, reducing individual variability.
• Registration: FDA-registered; IRB-approved and governed in accordance with FDA regulations; registered at ClinicalTrials.gov (NCT05233761).
• Participants: approximately 125 insomnia-suffering adults from across the United States.
• Measurement: objective sleep data captured with WHOOP, a wrist-worn wearable sleep-tracking device; subjective feedback via participant surveys. A medical monitor tracked adverse events throughout.

Results

Participants with severe insomnia experienced increased deep and REM sleep and decreased light sleep after taking Defined Sleep. Restorative sleep (deep + REM) increased by up to one hour per night over a one-month period; participants in the low-baseline responder subgroup experienced increases of up to 2X, as measured by validated wrist-worn actigraphy. Subjectively, the majority of participants reported improved sleep quality and duration.

These outcomes concern sleep architecture — the objectively measured proportion of time spent in deep (slow-wave) and REM stages — which is distinct from sleep onset (time to fall asleep), sleep continuity (awakenings), and subjective sleep quality.

Safety findings

• No adverse events reported, despite careful tracking by a medical monitor
• Non-sedating; no effect on heart rate or heart rate variability
• No risk profile for dependency observed

Notable subgroup: shift workers

Individuals who sleep during the day (for example, night-shift workers) and had severe insomnia were highly responsive to treatment with Defined Sleep according to trial data.

Limitations

Single trial; wearable sleep-tracking actigraphy rather than in-lab polysomnography; one-month treatment period. Some participants who enrolled in the study did not display insomnia symptoms.

Read the published study Key findings: one-page summary