Eligibility Details:
Inclusion Criteria:
- Subject is willing and able to provide consent.
- Subject has ability to read and understand the instructions for the study.
- Subject is willing to adhere to study procedures.
Exclusion Criteria:
1. Subject has presence of mild, moderate, or severe Major Depressive Disorder Episode,
based on DSM-IV criteria for diagnosis as documented by clinician administered M.I.N.I
OR HAMD-17 rating scale score >7.
2. Subject has bipolar disorder.
3. Subject has active psychotic symptoms.
4. Subject has known or is suspected to have a personality disorder.
5. Subject has current suicidality of medium or high risk as determined by M.I.N.I. or
HAMD-17 item #3 score of 3 of higher.
6. Subject has history of central or obstructive sleep apnea OR has a STOP-BANG score of
≥5 OR has a Home Sleep Test assessment (ApneaLink, ResMed) demonstrating AHI≥15.
7. Subject has a pacemaker.
8. Subject currently uses benzodiazepines, sedative-hypnotics, or trazadone on a
scheduled basis OR will be likely be prescribed such medication during the 8-week
observational phase of the study.
9. Subject currently uses antipsychotic medication for any indication OR will be likely
be prescribed such medication during the 8-week observational phase of the study.
10. Subject currently uses chronotropic medication, such as beta-blockers, digoxin,
sinoatrial/atrioventricular nodal-acting calcium channel blockers, and amiodarone.
11. Subject is suspected or known to have active alcohol or drug abuse (including but not
limited to abuse of marijuana).
12. Subject has a terminal illness.
13. For female subjects, subject is currently known to be pregnant or lactating.
14. Subject has any other acute or chronic condition that in the investigators opinion
would preclude the subject from being able to meet all of the protocol requirements,
or would compromise the subject's safety during participation in the study, as judged
by the investigator.
15. Subject is currently participating in another clinical study, or participated in a
clinical study in the past 30 days during which an investigational device or drug was
used.