Insomnia
Conditions
Keywords
insomnia, sleep, Bioboosti, Biomobie, device
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
Interventions
DEVICEBioboosti
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.
Sponsors
Brigham and Women's Hospital
Biomobie
Harvard University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index | Baseline to 2 weeks | 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. |
| Pittsburgh Sleep Quality Index | Baseline to 2 weeks | 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. |
| Daytime Sleepiness | Baseline to 2 weeks | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMilena Pavlova, MD
Brigham and Women's Hospital
Participant flow
Pre-assignment details
Bioboosti arm was only arm to enroll. No participants were enrolled in the "sustained efficacy" or "insomnia and migraine arms" as seen in results section and study publication
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants |
| Age, Continuous | 45.6 Years STANDARD_DEVIATION 17.1 |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 20 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 20 | 0 / 0 | 0 / 0 |
Outcome results
None listed