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Validation of the Sleep Assessment Algorithm in the Medical Application Nightly

NCT03532269 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-05-22

No results posted yet for this study

Summary

The Nightly medical application prototype is a potential, non-invasive class I medical device. The application has the potential to combine both diagnostic and therapeutic procedures for sleep. At home, Nightly measures the user's motion during sleep and then records the sleep pattern from the received data. The obtained data are then used for the diagnosis of sleep disorders (REM and NREM sleep). Using acoustic and visual stimulation, the application has the capability to support the natural process of falling asleep, provide a better night's sleep by minimizing sleep deprivation and nightmares, while awakening the user at the appropriate moment (during light sleep).

Conditions

  • Sleep Disorder
  • Nightmare

Interventions

DEVICE

Nightly App

The Nightly application will be installed independently on the user's smartphone. Once the user has set up their account and has logged in, they can then perform regular sleep quality assessments. In order to record a measurement, the user must first select a film (first screen) and watch it (second screen), the visualizations and acoustics aid in the process of falling asleep. After the film finishes, the participant places the phone on the corner of the bed, firstly with the screen facing up, and then under his/her pillow. Throughout the night, the application registers sleep phases that will be analyzed later.

Sponsors & Collaborators

  • DreamJay Sp. z o. o.

    lead INDUSTRY

Principal Investigators

  • Wojciech Jernajczyk, PhD · Institute of Neurology and Psychiatry

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2017-12-14
Completion
2018-01-31

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03532269 on ClinicalTrials.gov