Validation of the Sleep Assessment Algorithm in the Medical Application Nightly

NCT ID: NCT03532269

Last Updated: 2018-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2018-01-31

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).

Conditions

Sleep Disorder; Nightmare

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

A: 3rd night with acoustic stimulation

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

Group Type: EXPERIMENTAL

Nightly App

Intervention Type: 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.

B: 2nd night with acoustic stimulation

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

Group Type: EXPERIMENTAL

Nightly App

Intervention Type: 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.

Interventions

Nightly App

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

DreamJay Sp. z o. o.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wojciech Jernajczyk, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute of Neurology and Psychiatry

Locations

Institute of Psychiatry and Neurology in Warsaw

Warsaw, , Poland

Countries

Poland

Other Identifiers

001_Nightly_2017

Identifier Type: -

Identifier Source: org_study_id