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Completed

NCT Number: NCT03532269

Validation of the Sleep Assessment Algorithm in the Medical Application Nightly

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).

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Key information

Conditions

Sleep Disorder Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Nightmare Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Wake Disorders Tauopathies

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Psychiatry and Neurology in Warsaw

Warsaw, 02-957, Poland

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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)

Exclusion criteria

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Through study completion - after 3rd night of PSG

    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.

Secondary outcomes

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

    Time frame: Through study completion - after 3rd night of PSG

    The ICC value when evaluating the accuracy of recognizing sleep phases and vigilance using the Nightly application and the reference method should be no less than the ICC when comparing actigraphy and the reference method

  2. The incidence of arousal and wakening's

    Time frame: Through study completion - after 3rd night of PSG

    The stimulation produced by the Nightly application should not significantly affect the incidence of arousal and wakening's (when compared to analogous conditions without stimulation) with presumed statistical significance (p = 0.05). In other words, the aim of the experiment is to provide evidence that the distribution of arousals and wakening's measured in the study without stimulation is not statistically different from the distribution of the number of events during the Nightly application stimulation session

  3. Evaluate the effect of acoustic stimulation - total sleep time

    Time frame: Through study completion - after 3rd night of PSG

    Total sleep time will be measured.

  4. Evaluate the effect of acoustic stimulation - wake after sleep onset

    Time frame: Through study completion - after 3rd night of PSG

    Wake after sleep onset will be measured.

  5. Evaluate the effect of acoustic stimulation - sleep latency

    Time frame: Through study completion - after 3rd night of PSG

    Sleep latency will be measured.

Sponsors and collaborators

Lead sponsor

DreamJay Sp. z o. o.

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
May 22, 2018
Registry last updated
May 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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