Sleep DisorderNCT03532269
Validation of the Sleep Assessment Algorithm in the Medical Application Nightly
A study testing Nightly App in people with Sleep Disorder and Nightmare, run by DreamJay Sp. z o. o. at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorder, Nightmare
- What is being tested?
- Nightly App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePoland
- Study dates
- 1 Sep 2017to 31 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of the Sleep Assessment Algorithm in the Medical Application Nightly and Comparing it to Polysomnography in 24 Healthy Individuals
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).
Read the 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
- Being tested
- Nightly App
- Keywords
- sleep, nightmare, app
- Medical subject headings
- Sleep Wake Disorders, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nightly AppDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| A: 3rd night with acoustic stimulation | Experimental | Arm A: PSG (3 nights) with Nightly App - acoustic stimulation during the 3rd night. Receives: Device: Nightly App |
| B: 2nd night with acoustic stimulation | Experimental | Arm B: PSG (3 nights) with Nightly App - acoustic stimulation during the 2nd night. Receives: Device: Nightly App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion - after 3rd night of PSG
Secondary outcomes (5)
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
Measured: Through study completion - after 3rd night of PSG
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
Measured: Through study completion - after 3rd night of PSG
Evaluate the effect of acoustic stimulation - total sleep time
Total sleep time will be measured.
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.
Measured: Through study completion - after 3rd night of PSG
Evaluate the effect of acoustic stimulation - sleep latency
Sleep latency will be measured.
Measured: Through study completion - after 3rd night of PSG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start1 Sep 2017
- Primary completion14 Dec 2017
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- DreamJay Sp. z o. o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wojciech Jernajczyk, PhD, Principal investigator, Institute of Neurology and Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03532269
- Sponsor's protocol ID
- 001_Nightly_2017
- Status last verified
- May 2018
- First submitted
- 16 Oct 2017
- Last updated
- 22 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Sleep Assessment Algorithm in the Medical Application Nightly and Comparing it to Polysomnography in 24 Healthy Individuals
- ClinicalTrials.gov ID
- NCT03532269
- Acronym / sponsor ID
- 001_Nightly_2017
- Conditions
- Sleep Disorder, Nightmare
- Keywords
- sleep, nightmare, app
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- DreamJay Sp. z o. o.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 14 Dec 2017 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 22 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: 3rd night with acoustic stimulation | Experimental | Device: Nightly AppArm A: PSG (3 nights) with Nightly App - acoustic stimulation during the 3rd night. |
| B: 2nd night with acoustic stimulation | Experimental | Device: Nightly AppArm B: PSG (3 nights) with Nightly App - acoustic stimulation during the 2nd night. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nightly AppThe 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. | Device | A: 3rd night with acoustic stimulation, B: 2nd night with acoustic stimulation |
Primary outcome
The ICC for distribution of the total duration of standby periods during phases NREM and REM
Time frame: 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.
5 secondary outcomes
The ICC value when evaluating the accuracy of recognizing sleep phases and vigilance using the Nightly application
Time frame: Through study completion - after 3rd night of PSG
The incidence of arousal and wakening's
Time frame: Through study completion - after 3rd night of PSG
Evaluate the effect of acoustic stimulation - total sleep time
Time frame: Through study completion - after 3rd night of PSG
Evaluate the effect of acoustic stimulation - wake after sleep onset
Time frame: Through study completion - after 3rd night of PSG
Evaluate the effect of acoustic stimulation - sleep latency
Time frame: Through study completion - after 3rd night of PSG
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wojciech Jernajczyk, PhD principal investigator
Institute of Neurology and Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nightly App in people with Sleep Disorder and Nightmare, run by DreamJay Sp. z o. o. at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ICC for distribution of the total duration of standby periods during phases NREM and REM (time frame: Through study completion - after 3rd night of PSG). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2018.