Clinical trial NCT03532269: Validation of the Sleep Assessment Algorithm in the Medical Application Nightly
Official title: Validation of the Sleep Assessment Algorithm in the Medical Application Nightly and Comparing it to Polysomnography in 24 Healthy Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disorder
Nightmare
Keywords: sleep
nightmare
app
Lead sponsor: DreamJay Sp. z o. o.
Sponsor class: INDUSTRY
First posted: 2018-05-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).

Eligibility criteria: 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.

Primary outcomes:
measure: The ICC for distribution of the total duration of standby periods during phases NREM and REM
timeFrame: Through study completion - after 3rd night of PSG
Secondary outcomes:
measure: The ICC value when evaluating the accuracy of recognizing sleep phases and vigilance using the Nightly application
timeFrame: Through study completion - after 3rd night of PSG
measure: The incidence of arousal and wakening's
timeFrame: Through study completion - after 3rd night of PSG
measure: Evaluate the effect of acoustic stimulation - total sleep time
timeFrame: Through study completion - after 3rd night of PSG
measure: Evaluate the effect of acoustic stimulation - wake after sleep onset
timeFrame: Through study completion - after 3rd night of PSG
measure: Evaluate the effect of acoustic stimulation - sleep latency
timeFrame: Through study completion - after 3rd night of PSG
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Institute of Psychiatry and Neurology in Warsaw
Study officials:
affiliation: Institute of Neurology and Psychiatry
name: Wojciech Jernajczyk, PhD
role: PRINCIPAL_INVESTIGATOR
References: