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Validation of the Sleep Assessment Algorithm in the Medical Application Nightly

Primary Purpose

Sleep Disorder, Nightmare

Status

Completed

Phase

Not Applicable

Locations

Poland

Study Type

Interventional

Intervention

Nightly App

About this trial

This is an interventional other trial for Sleep Disorder focused on measuring sleep, nightmare, app

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Institute of Psychiatry and Neurology in Warsaw

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

A: 3rd night with acoustic stimulation

B: 2nd night with acoustic stimulation

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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

The incidence of arousal and wakening's

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

Evaluate the effect of acoustic stimulation - total sleep time

Total sleep time will be measured.

Evaluate the effect of acoustic stimulation - wake after sleep onset

Wake after sleep onset will be measured.

Evaluate the effect of acoustic stimulation - sleep latency

Sleep latency will be measured.

Full Information

NCT ID

NCT03532269

First Posted

October 16, 2017

Last Updated

May 9, 2018

Sponsor

DreamJay Sp. z o. o.

1. Study Identification

Unique Protocol Identification Number

NCT03532269

Brief Title

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

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

September 1, 2017 (Actual)

Primary Completion Date

December 14, 2017 (Actual)

Study Completion Date

January 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

DreamJay Sp. z o. o.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Disorder, Nightmare

Keywords

sleep, nightmare, app

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A: 3rd night with acoustic stimulation

Arm Type

Experimental

Arm Description

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

Arm Title

B: 2nd night with acoustic stimulation

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Nightly App

Intervention Description

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 Outcome Measure Information:

Title

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

Description

Time Frame