Clinical trial NCT02924116: Bioboosti Device for Insomnia Treatment
Official title: Use of Bioboosti Non-pharmacologic Device for Insomnia Treatment: A Pilot Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Insomnia
Keywords: insomnia
sleep
Bioboosti
Biomobie
device
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Biomobie
name: Harvard University
First posted: 2016-10-05
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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).
Primary purpose: TREATMENT

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.

Detailed 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

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

Primary outcomes:
measure: Change in Insomnia symptoms before treatment to after treatment
timeFrame: Week 1, Week 4
measure: Change in Sleepiness before treatment to after treatment
timeFrame: Week 1, Week 4
Secondary outcomes:
measure: Change in EEG from before treatment to after treatment
timeFrame: Week 2, Week 4
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Faulkner Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Milena Pavlova, MD
role: PRINCIPAL_INVESTIGATOR
References: