Validation of the Sleep Assessment Algorithm in the Medical Application Nightly

Sleep Disorder Clinical Trial

Official title: Validation of the Sleep Assessment Algorithm in the Medical Application Nightly and Comparing it to Polysomnography in 24 Healthy Individuals

Status Completed

Clinical Trial 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).

Clinical Trial Description

The study is a cohort, single-center, randomized trial. The duration of one participant included in the study is three successive nights. Visual analysis of polysomnographic recordings taken from the second and third nights will be performed independently by two independent, blinded experts. According to the sleep architecture description derived from the Nightly application, polysomnographic and actigraphy studies will be assessed using the intraclass correlation coefficient, ICC, version "Two-Way Random". Parameters of the sleep architecture will be the average total length of the individual sleep phases (provided with standard deviations and coefficients of variability defined as the quotient of standard deviation and mean). ;

Related Conditions & MeSH terms

• Nightmare
• Parasomnias
• Sleep Disorder
• Sleep Wake Disorders

• NCT number: NCT03532269
• Study type: Interventional
• Source: DreamJay Sp. z o. o.
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Completion date: January 31, 2018