| Eligibility |
Inclusion Criteria:
- Participant is = 18 and = 80 years old
- Participant understands the study requirements and is able and willing to provide
written informed consent
- Participant is without significant limitation in ability to participate in the study,
in the opinion of the investigator
- Participant belongs to one of the following participant groups as determined by
screening questionnaires:
- Typical sleepers (i.e., STOP-Bang score of 0-2 or OSA50 < 5, Insomnia Severity
Index (ISI) < 8, and Epworth Sleepiness Scale (ESS) < 10), and no evidences of
sleep-disordered breathing at the PSG evaluation
- Insomnia sleepers (i.e., ISI > 10 and PSG AHI < 5)
- Sleep apnea sleepers (i.e., STOP-Bang score of 3-8 or OSA50 = 5) or moderate to
severe obstructive sleep apnea (PSG AHI =5))
- Participant has agreed to abstain from caffeine, nicotine, alcohol, and cannabis
products for 8 hours prior to the In-Lab Screening Visit and until the visit is
completed
- Exception - unless the participant use of product has approval from the Principal
Investigator
- Participant has agreed to abstain from OTC or PRN medications that are not regularly
used on a daily basis and may affect sleep/wakefulness for 24 hours prior to the
In-Lab Overnight Visit and during the study visit
- Exception - unless the participant uses OTC or PRN medication on a routine basis
and has approval from the Principal Investigator
Exclusion Criteria: Conditions based on self-report of having been told by a doctor of a
formal diagnosis
- Presence of any of the following diagnosed sleep, medical, or psychiatric disorders:
- Sleep
- Narcolepsy
- Restless leg syndrome
- Circadian rhythm sleep disorder
- Periodic Limb Movement Disorder
- REM Sleep behavior disorder
- Medical
- Epilepsy or other seizure disorder
- Renal failure or chronic kidney disease
- Acute or chronic infection that may interfere with the study
- Movement neurological disorder that impairs movement or autonomic stability
(e.g. Parkinson's disease, Huntington's disease)
- Cardiopulmonary diseases (e.g. heart failure, chronic obstructive pulmonary
disease, ventilatory disorders)
- Persistent arrhythmias and dysrhythmias
- Severe neuromuscular disease (e.g. Amyotrophic lateral sclerosis [ALS])
- Psychiatric
- Severe significant mood disorder (e.g. depression, bipolar disorder)
- Substance use disorder
- Participant uses supplemental oxygen during the day or night
- Participant is unwilling to cease use of CPAP or oral appliance for sleep-disordered
breathing during the In-Lab Overnight Visit; or cessation is deemed to be of
substantial risk in the opinion of the Principal Investigator
- Women who are pregnant, lactating, or breastfeeding
- Participant takes prescription stimulants, sedatives, opioids, alpha blockers, short
acting nitrates, or any other medication that, in the opinion of the Principal
Investigator and study team, impacts their sleep behavior
- Use of any sleep medications (over-the-counter or prescription) in the previous 24
hours for Typical Sleepers
- Participant has a cardiac pacemaker, implantable defibrillator, medical pump, or other
implantable medical electronic device
- Participant has Shift Work Sleep Disorder (SWSD) or is a night-shift worker
- Participant has traveled >3 time zone within two weeks prior to study
- Participant is not fluent at reading and speaking English
- Participant is deemed not to be a candidate for the study, in the opinion of the
Principal Investigator
- Known severe allergy to nickel or metal jewelry
- Open injury or rash where the study device or comparator will be worn
- Known severe allergy to polyester, nylon, or spandex material
- Enrolled participants who meet exclusion criteria after PSG, upon confirmation with
the principal investigator and study team, will be discontinued and excluded from
primary analyses.
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