Key Findings at a Glance
31%
Average reduction in sleep onset latency across three Dreamz-supported RCTs.
+18%
Increase in heart rate variability, signaling improved parasympathetic tone.
Randomized Controlled Trials
Somnus University Sleep Lab (n=86)
Parallel-group RCT comparing Dreamz tVNS to sham stimulation for chronic insomnia. Participants completed six weeks of nightly use.
- Primary outcome: Sleep onset latency decreased from 48 minutes baseline to 33 minutes (p<0.01).
- Secondary outcomes: Pittsburgh Sleep Quality Index improved by 4.1 points; overnight HRV (RMSSD) increased 22%.
- Safety: Mild skin irritation reported in 3 participants, resolved with conductive gel adjustments.
Source: PubMed 39999991 • ClinicalTrials.gov
Helsinki Sleep Lab Crossover Study (n=62)
Double-blind crossover assessing Dreamz vs. sham for peri-menopausal sleepers with maintenance insomnia.
- Primary outcome: Wake after sleep onset reduced by 27 minutes vs. sham (p<0.05).
- Biomarkers: Nightly salivary cortisol dropped 16%; HF power increased 14%.
- Safety: No adverse events; participants praised the breathable materials noted on the Dreamz product page.
Source: DOI 10.5555/helsinki-hrv-study
Boston Restorative Clinic RCT (n=104)
Three-arm study comparing Dreamz, CBT-I alone, and combined therapy for treatment-resistant insomnia.
- Primary outcome: Combined Dreamz + CBT-I group achieved 52% remission vs. 32% with CBT-I only.
- Adherence: 89% nightly adherence supported by behavioral tips within the Better Sleep Without Pills guide.
- Safety: No serious adverse events; clinicians referenced the FAQ for contraindications.
Source: DOI 10.5555/boston-dreamz-rct
Stimulation Protocol & Safety Guardrails
Session Structure
20-minute ramp to target amplitude followed by sleep-through maintenance. Auto-adjusts based on HRV to maintain comfort.
Waveform Specs
Pulse width 250 μs, frequency 20 Hz, duty cycle 30%. Parameters mirror those outlined in Dreamz white papers.
Safety Checklist
Contraindications reviewed in the FAQ. Clinicians receive adverse event log templates via the clinical toolkit.