Bioboosti Device for Insomnia Treatment

Insomnia Clinical Trial

Official title:

Use of Bioboosti Non-pharmacologic Device for Insomnia Treatment: A Pilot Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02924116
• Other study ID #: 2016P000996
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 2016
• Est. completion date: December 2024

Study information

• Verified date: July 2023
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Insomnia is a common health complaint that is associated with discomfort, loss of productivity, poor health and higher use of healthcare. The use of non-pharmacologic treatments for insomnia has gained much attention in recent years. The investigators are conducting this research because a safe, non-pharmacologic treatment would benefit patients with insomnia, and to see if the Bioboosti device is an effective treatment for insomnia.

Subjects will include patients from the clinics who have the diagnosis of insomnia. Study staff will notify the treating physician of a potential subject. If the subject gives permission and would like to obtain more information, study staff will approach them and provide them with the consent form to review. Study staff may also contact them by phone to explain the study and recruit.

Subjects will be asked to make 5 visits:

Visit 1-- consent form, physical exam, vitals, pregnancy test, sleep log

Visit 2-- sleep questionnaires, urine test for hormones associated with sleep, sleep log, placement of EEG

Visit 3-- remove EEG, beginning of treatment with Bioboosti device, sleep log Treatment phase-- subjects use the Bioboosti at home for two weeks

Visit 4-- return of Bioboosti, sleep questionnaires, urine test for hormones associated with sleep, sleep log, placement of EEG

Visit 5-- remove EEG, collect sleep logs

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 21
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Device:
• Bioboosti
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.

Locations

Country	Name	City	State
United States	Brigham and Women's Faulkner Hospital	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Biomobie, Harvard University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Insomnia symptoms before treatment to after treatment	Within subject comparisons before and after treatment, subjects answer questions on their sleep habits.	Week 1, Week 4
Primary	Change in Sleepiness before treatment to after treatment	Within subject comparisons before and after treatment, subjects answer questions on sleep difficulty.	Week 1, Week 4
Secondary	Change in EEG from before treatment to after treatment	Ambulatory EEG will be used before treatment and after treatment, using sleep montage per standard AASM criteria and scored by a registered polysomnography technologist using AASM guidelines. Sleep architecture will be reported as the percent of time the subject remains in the different sleep stages. Specifically we will compare percent in REM sleep before and after treatment. The waveform of the EEG that will be assessed during teh study period is delta.	Week 2, Week 4