N/A
Completed N=20
Bioboosti Device for Insomnia Treatment
Source: ClinicalTrials.gov NCT02924116 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcomePrimary: Insomnia Severity Index — 5.4 Scores on a scale
Summary
The purpose of this study is to determine the effects of the Bioboosti device on sleep for patients who have been diagnosed with insomnia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Insomnia Severity Index |
5.4 | — |
| PRIMARY Pittsburgh Sleep Quality Index |
4.1 | — |
| PRIMARY Daytime Sleepiness |
1.7 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with insomnia
Exclusion Criteria
- Untreated moderate or severe sleep apnea
- Major circadian rhythm disorder
- Pregnant women
- Breastfeeding
- Cardiac pacemaker
- Cancer
- Severe conditions related to heart, brain, kidney and hematopoietic system
- Severe/unstable angina pectoris
- Arteria coronaria/ peripheral arterial bypass graft
- Acute congestive heart failure
- Renal insufficiency
- Mechanical intestinal obstruction
- Any electrical devices
Data sourced from ClinicalTrials.gov (NCT02924116). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.