Validation of the Sleep Assessment Algorithm in the Medical Application Nightly

NCT03532269 | Completed DMC

• 1 other identifier: 001_Nightly_2017
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

sleep; nightmare; app

Outcome Measures

Primary Outcomes (1)

• The ICC for distribution of the total duration of standby periods during phases NREM and REM

  The ICC for distribution of the total duration of standby periods during phases NREM and REM should not be less than 0.6 in the comparative analysis of results provided by the Nightly application and at least one of the visual recordings from polysomnography.

  Through study completion - after 3rd night of PSG

Secondary Outcomes (5)

• The ICC value when evaluating the accuracy of recognizing sleep phases and vigilance using the Nightly application

  Through study completion - after 3rd night of PSG

• The incidence of arousal and wakening's

  Through study completion - after 3rd night of PSG

• Evaluate the effect of acoustic stimulation - total sleep time

  Through study completion - after 3rd night of PSG

• Evaluate the effect of acoustic stimulation - wake after sleep onset

  Through study completion - after 3rd night of PSG

• Evaluate the effect of acoustic stimulation - sleep latency

  Through study completion - after 3rd night of PSG

Study Arms (2)

A: 3rd night with acoustic stimulation

EXPERIMENTAL

Arm A: PSG (3 nights) with Nightly App - acoustic stimulation during the 3rd night.

Device: Nightly App

B: 2nd night with acoustic stimulation

EXPERIMENTAL

Arm B: PSG (3 nights) with Nightly App - acoustic stimulation during the 2nd night.

Device: Nightly App

Interventions

Nightly App DEVICE

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.

A: 3rd night with acoustic stimulation; B: 2nd night with acoustic stimulation

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: 15 M, 15 F
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Any healthy individual who meets all the following criteria may be included in the study:
• Age 18 to 40 years.
• Signed Informed Consent Form for participation in the study
• No chronic illnesses (A medical interview will be conducted during the participants first visit)
• Does not take any medication chronically (According to the medical interview with the participants during the first visit)

You may not qualify if:

• A person who meets any one of the following criteria cannot be included in the study:
• Primary sleep disorders. (An in-depth medical interview during the first visit to be supplemented with: Holland Sleep Disorders Questionnaire which evaluates the risk of primary sleep disorders according to the International Classification of Sleep Disorders (ICSD-3), Athens insomnia scale which assesses the risk of insomnia and the STOP-BANG scale, evaluates the risk for sleep apnea; a journal will also be kept noting dreams between the first and second visit.
• History of cancer or active cancer.
• Disorders of the nervous system (e.g. epilepsy, migraine).
• Mental disorders (e.g. depression, bipolar disorder, schizophrenia).
• Active infection during the study. (Medical history, body temperature measurement and physical examination)
• Consuming within 12 hours preceding the sleep examination: coffee, caffeinated teas or other beverages containing caffeine, caffeine, or other stimulants.
• Consuming alcohol on the day of the examination.
• Pregnancy and lactation (based on the patient's own declaration, pregnancy test is not planned prior to the examination).
• Any contraindications to participate in the examination in the Investigator's opinion.

Sponsors & Collaborators

• DreamJay Sp. z o. o.: lead

Study Sites (1)

Institute of Psychiatry and Neurology in Warsaw

Warsaw, 02-957, Poland

Location

MeSH Terms

Conditions

Sleep Wake Disorders; Alzheimer Disease

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders

Study Officials

• Wojciech Jernajczyk, PhD

  Institute of Neurology and Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2017
• First Posted: May 22, 2018
• Study Start: September 1, 2017
• Primary Completion: December 14, 2017
• Study Completion: January 31, 2018
• Last Updated: May 22, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)