The purpose of this study is to determine the effects of the Bioboosti device on sleep for patients who have been diagnosed with insomnia.
Condition or disease Intervention/treatment Phase
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
Read more, here: https://clinicaltrials.gov/ct2/show/NCT02924116