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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: 3rd night with acoustic stimulation | Experimental | Arm A: PSG (3 nights) with Nightly App - acoustic stimulation during the 3rd night. |
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| B: 2nd night with acoustic stimulation | Experimental | Arm B: PSG (3 nights) with Nightly App - acoustic stimulation during the 2nd night. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion - after 3rd night of PSG |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Through study completion - after 3rd night of PSG |
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Inclusion Criteria:
Any healthy individual who meets all the following criteria may be included in the study:
Exclusion Criteria:
A person who meets any one of the following criteria cannot be included in the study:
15 M, 15 F
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| Name | Affiliation | Role |
|---|---|---|
| Wojciech Jernajczyk, PhD | Institute of Neurology and Psychiatry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Psychiatry and Neurology in Warsaw | Warsaw | 02-957 | Poland |
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| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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 | Through study completion - after 3rd night of PSG |
| Evaluate the effect of acoustic stimulation - total sleep time | Total sleep time will be measured. | Through study completion - after 3rd night of PSG |
| Evaluate the effect of acoustic stimulation - wake after sleep onset | Wake after sleep onset will be measured. | Through study completion - after 3rd night of PSG |
| Evaluate the effect of acoustic stimulation - sleep latency | Sleep latency will be measured. | Through study completion - after 3rd night of PSG |
| D001523 | Mental Disorders |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |