Validation of the Sleep Assessment Algorithm in the Medical Application Nightly

Not Applicable

Completed

• Conditions: Nightmare; Sleep Disorder

• Registration Number: NCT03532269
• Lead Sponsor: DreamJay Sp. z o. o.

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).

Detailed 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).

Study Timeline

• Study Start: 2017-09-01
• Study First Submitted: 2017-10-16
• Primary Completion: 2017-12-14
• Study Completion: 2018-01-31
• Status Verified: 2018-05
• Study First Submitted QC: 2018-05-09
• Last Update Submitted: 2018-05-09
• Study First Posted: 2018-05-22
• Last Update Posted: 2018-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Any healthy individual who meets all the following criteria may be included in the study:

1. Age 18 to 40 years.
2. Signed Informed Consent Form for participation in the study
3. No chronic illnesses (A medical interview will be conducted during the participants first visit)
4. 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:

1. 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.
2. History of cancer or active cancer.
3. Disorders of the nervous system (e.g. epilepsy, migraine).
4. Mental disorders (e.g. depression, bipolar disorder, schizophrenia).
5. Active infection during the study. (Medical history, body temperature measurement and physical examination)
6. Consuming within 12 hours preceding the sleep examination: coffee, caffeinated teas or other beverages containing caffeine, caffeine, or other stimulants.
7. Consuming alcohol on the day of the examination.
8. Pregnancy and lactation (based on the patient's own declaration, pregnancy test is not planned prior to the examination).
9. Any contraindications to participate in the examination in the Investigator's opinion.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The ICC for distribution of the total duration of standby periods during phases NREM and REM	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 Outcome Measures

Name	Time	Method
Evaluate the effect of acoustic stimulation - wake after sleep onset	Through study completion - after 3rd night of PSG	Wake after sleep onset will be measured.
Evaluate the effect of acoustic stimulation - total sleep time	Through study completion - after 3rd night of PSG	Total sleep time will be measured.
Evaluate the effect of acoustic stimulation - sleep latency	Through study completion - after 3rd night of PSG	Sleep latency will be measured.
The incidence of arousal and wakening's	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
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 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

Trial Locations

Locations (1)

Institute of Psychiatry and Neurology in Warsaw; 🇵🇱 Warsaw, Poland