Bioboosti Device for Insomnia Treatment

NCT02924116 | Completed Results

• 1 other identifier: 2016P000996
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Insomnia

Keywords

insomnia; sleep; Bioboosti; Biomobie; device

Outcome Measures

Primary Outcomes (3)

• Insomnia Severity Index

  Change in Insomnia Severity Index (ISI) will be measured. The Insomnia Severity Index (ISI) is a short, 7-item self-report questionnaire used to screen for insomnia, assess its severity, and monitor treatment effectiveness by evaluating sleep problems (like falling/staying asleep, early waking) and their impact on daytime functioning over the past two weeks. Scoring from 0 to 28, with higher scores indicating greater severity, the ISI helps classify insomnia as none, subthreshold, moderate, or severe, guiding clinical decisions in research and practice. This will be done before and after treatment.

  Baseline to 2 weeks

• Pittsburgh Sleep Quality Index

  The change in the Pittsburgh Sleep Quality Index (PSQI) from baseline to 2 weeks will be measured. The PSQI is a widely used, self-rated questionnaire that assesses sleep quality and disturbances over a one-month period. It consists of 19 items that generate seven component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction), which are summed to yield a global score ranging from 0 to 21. Higher global scores indicate worse sleep quality. Change will be calculated as the PSQI score at 2 weeks minus the PSQI score at baseline (Week 2 - Baseline). Because lower PSQI scores indicate better sleep quality, a negative change score reflects an improvement in sleep quality, whereas a positive change score reflects worsening sleep quality.

  Baseline to 2 weeks

• Daytime Sleepiness

  Daytime sleepiness will be assessed using a Visual Analog Scale (VAS) from baseline to 2 weeks. The VAS is a subjective measure consisting of a 100 mm horizontal line anchored by "not at all sleepy" (0 mm) on the left and "extremely sleepy" (100 mm) on the right. Participants mark the point on the line that best represents their current level of daytime sleepiness. Higher scores indicate greater sleepiness. Change will be calculated as the VAS score at 2 weeks minus the VAS score at baseline (Week 2 - Baseline). Because higher scores indicate greater sleepiness, a negative change score reflects a reduction in daytime sleepiness (improvement), whereas a positive change score reflects an increase in daytime sleepiness (worsening). The mean change and standard deviation of the change scores will be reported.

  Baseline to 2 weeks

Study Arms (3)

Bioboosti

EXPERIMENTAL

Treatment with the Bioboosti device for two weeks. The device produces a pulsed micro-magnetic field. Subjects will use it once a day for about one hour, before habitual sleep time.

Device: Bioboosti

Sustained Efficacy

EXPERIMENTAL

Treatment with Bioboosti device for a year. In order to see if the device has sustained efficacy in treating insomnia. Subjects will use it once a day for about one hour, before habitual sleep time.

Device: Bioboosti

Insomnia and migraine

EXPERIMENTAL

Treatment with the Bioboosti device for a month. Subjects will use it once a day for about one hour, before habitual sleep time.

Device: Bioboosti

Interventions

Bioboosti DEVICE

Subjects will place the device on the palm of their hand for 8 minutes. There is a light on the device that changes to indicate that the 8 minutes have passed. They will then place it on the palm of the other hand and keep it there for 8 minutes. Alternating 8-minute cycles between hands will be done up to 6 times.

Bioboosti; Insomnia and migraine; Sustained Efficacy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with insomnia

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Biomobie: collaborator
• Harvard University: collaborator

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Brigham and Women's Faulkner Hospital

Boston, Massachusetts, 02130, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Results Point of Contact

• Title: Milena Pavlova, M.D.
• Organization: Brigham and Women's Hospital

mpavlova@bwh.harvard.edu

(617) 983-7580

Study Officials

• Milena Pavlova, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: Subjects will complete the first arm of the study. Upon completion, the subjects will be offered enrollment into the next long term arm of the study (Sustained Efficacy).

Study Record Dates

• First Submitted: September 20, 2016
• First Posted: October 5, 2016
• Study Start: September 1, 2016
• Primary Completion: November 1, 2024
• Study Completion: April 1, 2025
• Last Updated: March 4, 2026
• Results First Posted: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)