← Back to Search

Vibro-acoustic Device for Sleep Duration (Sleep-Vibe Trial)

N/A

Recruiting

Led By Paul D Patterson, PhD

Research Sponsored by Daniel Patterson, PhD, NRP

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must be 18 years of age or older

Participants must not be prescribed medications or take over-the-counter medications that may impact blood pressure or heart rate

Must not have

Participants must not take medications with sedative effects or effects on sleep during the study protocol and data collection periods

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured at two time points. first, measured at 10 minutes after waking from the 30-minute nap opportunity during the simulated night shift. second, measured at 10 minutes after participants wake from the 5-hour recovery sleep period..

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a non-invasive sleep aid device's impact on sleep and performance during naps after simulated night shift work. It will measure effects on sleep duration, architecture, blood pressure,

Who is the study for?

This trial is for individuals who work night shifts and are interested in testing a wrist-worn device designed to improve sleep and performance. Participants should be willing to have their sleep, heart rate variability, blood pressure, and motor skills monitored.

What is being tested?

The study tests the ApolloNeuro device's ability to enhance sleep duration and quality during/after night shifts. It also examines its impact on psychomotor performance post-sleep by monitoring vital signs and subjective sleep assessments.

What are the potential side effects?

Since the device uses non-invasive vibrations, side effects may be minimal but could include discomfort from wearing the device or potential disruption of sleep patterns if the vibration is not soothing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I am not taking any medication that affects my blood pressure or heart rate.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not taking any sleep or sedative medications during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at two time points. first, measured at 10 minutes after waking from the 30-minute nap opportunity during the simulated night shift. second, measured at 10 minutes after participants wake from the 5-hour recovery sleep period..

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured at two time points. first, measured at 10 minutes after waking from the 30-minute nap opportunity during the simulated night shift. second, measured at 10 minutes after participants wake from the 5-hour recovery sleep period..

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at two time points. first, measured at 10 minutes after waking from the 30-minute nap opportunity during the simulated night shift. second, measured at 10 minutes after participants wake from the 5-hour recovery sleep period.. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean sleep duration

Secondary study objectives

Mean number of lapses in psychomotor performance at 10 minutes after participants wake from sleep period

Proportion with a dip in systolic blood pressure during 30-min nap opportunity that is greater than or equal to 10%

Proportion with a dip in systolic blood pressure during the 5-hour recovery sleep period

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: No device applied followed by the Apollo device appliedExperimental Treatment1 Intervention

Participants will be randomized to first complete the protocol without the Apollo Neuro device applied then complete a condition with the Apollo Neuro device applied immediately before, during, and immediately after sleep opportunities during the study protocol.

Group II: Apollo device applied followed by no device appliedExperimental Treatment1 Intervention

Participants will be randomized to first wear the Apollo Neuro device immediately before, during, and immediately after sleep opportunities during the study protocol. Next, the participant will complete the protocol without the device.

0 / 3Eligibility criteria met