PSG Validation Study of Zensorium Biosensing Wearable Device

NCT ID: NCT04200495

Last Updated: 2021-02-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 68 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-20
• Study Completion Date: 2020-10-28

Brief Summary

The objective of this study is to collect data comparing the Zensorium Biosensing Wearable Device (zBWD) to polysomnography (PSG) in individuals with Sleep-Wake Disorders. zBWD is similar to other wearable devices (e.g., fitbit and apple watch) that use an optical light sensor and Tri-axis Accelerometer to record steps, activity, sleep/awake states, sleep staging, and statistical variation of pulse pressure to track stress. Specifically, it is designed to report sleep duration, non-rapid eye movement (NREM) and REM sleep duration. However, zBWD has not been validated against PSG for sleep tracking in healthy controls or in individuals with sleep-wake disorders.

Detailed Description

Subjects known to have or not have sleep-wake disorder, as well as healthy subjects, will be enrolled if they otherwise meet all the inclusion criteria, and none of the exclusion criteria. Subject will be asked to complete several questionnaires and wear the zBWD for 7-days, in an off-site (Home) study, followed by a single overnight PSG study to compare the zBWD data to the current gold standard of PSG. Subjects who have completed the study will also be sent a letter thanking them for their participation and offering a summary of the results of their sleep study.

Conditions

Sleep Wake Disorders; Healthy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy Controls

No sleep-wake disorder present

No interventions assigned to this group

Active Sleep-Wake Disorder

Presence of Sleep-Wake Disorder

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 1. Health status: Healthy, or those with sleep-wake disorders

Exclusion Criteria

1. Pregnancy

2. Currently smoking

3. Any respiratory disorder other than associated with Sleep/Wake Disorder or well-controlled asthma

4. Habitual use of medications known to affect respiratory function (e.g. opioids, benzodiazepines, etc).

5. Use of medication known to affect pulse pressure (Beta Blockers)

6. Atrial Fibrillation

7. Tattoos located on wrist

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nitto Denko Asia Technical Centre (NAT)

UNKNOWN

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Peter Colvonen

Assistant Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of California San Diego

San Diego, California, United States

Countries

United States

Other Identifiers

190705

Identifier Type: -

Identifier Source: org_study_id