Sleep DeprivationBASELNCT06027047
Breakthrough Anxiety and Sleep Evaluation Using Linked Devices and Smartphone Application Onar (BASEL)
An observational study of Sleep Deprivation and Sleep Hygiene, run by Raivotech.
Trial summary
Sleep is not simply the absence of wakefulness. Sleep is an active procedure, normally happening every night, and is absolutely vital. Good sleep is essential for our well-being. Survival without food can be further than without sleep. Work time and commuting time seem to affect total sleep time and night bedtime. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation, Sleep Hygiene, Sleepiness
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 15 Jan 2024
- Phase
- Observational
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Subjects using the application on a daily basis for at least 1 week prior to participation will be eligible for participation. After the first full week of data will be over, the application will show a message asking for participation in the study and acceptance of terms. Participants will continue using their smartwatch as usual and data will be collected from a period of 2 week for each subject. At the end of the 2-week period a new message will be asking the participant to complete the Hospital Anxiety and Depression Questionnaire (HADS) and the Epworth Sleepiness Scale (ESS) and the total score will be stored.
Who may be able to join
- Acceptance of terms of use of the application must be done prior to participation in the study.
- Male and female adults aged ≥18 years old and ≤60 years old.
- Subjects using the application on a daily basis for at least 1 week prior to participation.
Who cannot join
- History of alcohol or other substance abuse.
Trial locations and contacts
No sites are listed yet.
About this study
Sleep is not simply the absence of wakefulness. Sleep is an active procedure, normally happening every night, and is absolutely vital. Good sleep is essential for our well-being. Survival without food can be further than without sleep. Work time and commuting time seem to affect total sleep time and night bedtime. Social and work obligation can, therefore, suppress sleep time. Sleep deprived individuals may be facing anxiety and depression symptoms.
The aim of this study is to investigate the presence of anxiety and depression symptoms among adults with the use of the smartphone application Onar. Onar app will be used to gather information from wearable devices of the users including total sleep time, sleep efficiency, wake after sleep onset time. An established questionnaire (Hospital Anxiety Depression Scale/ HADS) will be used to quantify and detect the presence of anxiety and depression in the study population.
- Conditions
- Sleep Deprivation, Sleep Hygiene, Sleepiness, Sleep Driving, Depression, Anxiety, Anxiety Disorders
- Keywords
- smartphone, wearables, app, sleep, anxiety, depression
- Medical subject headings
- Sleep Deprivation, Sleep Hygiene, Sleepiness, Depression, Anxiety Disorders, Alzheimer Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the existence of depression and anxiety symptoms in the study population.
Comparison of HADS score with population standardized mean value.
Measured: 2 weeks
Secondary outcomes (4)
Correlation of depression and anxiety symptoms with Total sleep time (TST).
Total sleep time (TST).
Measured: 2 weeks
Correlation of depression and anxiety symptoms with Wake after sleep onset time (WASO).
Wake after sleep onset time (WASO).
Measured: 2 weeks
Correlation of depression and anxiety symptoms with Sleep Onset Latency (SOL).
Sleep Onset Latency (SOL).
Measured: 2 weeks
Correlation of depression and anxiety symptoms with Epworth Sleepiness Scale (ESS).
Epworth Sleepiness Scale (ESS).
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start1 Sep 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion15 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sleep DeprivationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Raivotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyriakos Karkoulias, Prof., Principal investigator, University Hospital of Patras, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06027047
- Sponsor's protocol ID
- ROA101
- Acronym
- BASEL
- Status last verified
- Aug 2023
- First submitted
- 30 Aug 2023
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sforza E, de Saint Hilaire Z, Pelissolo A, Rochat T, Ibanez V. Personality, anxiety and mood traits in patients with sleep-related breathing disorders: effect of reduced daytime alertness. Sleep Med. 2002 Mar;3(2):139-45. doi: 10.1016/s1389-9457(01)00128-9.
PubMed 14592233Bixler EO, Vgontzas AN, Lin HM, Calhoun SL, Vela-Bueno A, Kales A. Excessive daytime sleepiness in a general population sample: the role of sleep apnea, age, obesity, diabetes, and depression. J Clin Endocrinol Metab. 2005 Aug;90(8):4510-5. doi: 10.1210/jc.2005-0035. Epub 2005 Jun 7.
PubMed 15941867Horenstein A, Morrison AS, Goldin P, Ten Brink M, Gross JJ, Heimberg RG. Sleep quality and treatment of social anxiety disorder. Anxiety Stress Coping. 2019 Jul;32(4):387-398. doi: 10.1080/10615806.2019.1617854. Epub 2019 May 13.
PubMed 31082285Snaith RP. The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. 2003 Aug 1;1:29. doi: 10.1186/1477-7525-1-29.
PubMed 12914662
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breakthrough Anxiety and Sleep Evaluation Using Linked Devices and Smartphone Application Onar (BASEL)
- ClinicalTrials.gov ID
- NCT06027047
- Acronym / sponsor ID
- BASEL / ROA101
- Conditions
- Sleep Deprivation, Sleep Hygiene, Sleepiness, Sleep Driving, Depression, Anxiety, Anxiety Disorders
- Keywords
- smartphone, wearables, app, sleep, anxiety, depression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- RaivotechIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 15 Jan 2024 (estimated)
- First posted
- 7 Sep 2023 (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.
Sleep is not simply the absence of wakefulness. Sleep is an active procedure, normally happening every night, and is absolutely vital. Good sleep is essential for our well-being. Survival without food can be further than without sleep. Work time and commuting time seem to affect total sleep time and night bedtime. Social and work obligation can, therefore, suppress sleep time. Sleep deprived individuals may be facing anxiety and depression symptoms.
The aim of this study is to investigate the presence of anxiety and depression symptoms among adults with the use of the smartphone application Onar. Onar app will be used to gather information from wearable devices of the users including total sleep time, sleep efficiency, wake after sleep onset time. An established questionnaire (Hospital Anxiety Depression Scale/ HADS) will be used to quantify and detect the presence of anxiety and depression in the study population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Subjects using the application on a daily basis for at least 1 week prior to participation will be eligible for participation. After the first full week of data will be over, the application will show a message asking for participation in the study and acceptance of terms. Participants will continue using their smartwatch as usual and data will be collected from a period of 2 week for each subject. At the end of the 2-week period a new message will be asking the participant to complete the Hospital Anxiety and Depression Questionnaire (HADS) and the Epworth Sleepiness Scale (ESS) and the total score will be stored.
Key inclusion criteria (3 listed)
- Acceptance of terms of use of the application must be done prior to participation in the study.
- Male and female adults aged ≥18 years old and ≤60 years old.
- Subjects using the application on a daily basis for at least 1 week prior to participation.
Key exclusion criteria (1 listed)
- History of alcohol or other substance abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine the existence of depression and anxiety symptoms in the study population.
Time frame: 2 weeks
Comparison of HADS score with population standardized mean value.
4 secondary outcomes
Correlation of depression and anxiety symptoms with Total sleep time (TST).
Time frame: 2 weeks
Correlation of depression and anxiety symptoms with Wake after sleep onset time (WASO).
Time frame: 2 weeks
Correlation of depression and anxiety symptoms with Sleep Onset Latency (SOL).
Time frame: 2 weeks
Correlation of depression and anxiety symptoms with Epworth Sleepiness Scale (ESS).
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Background: PubMed 14592233Sforza E, de Saint Hilaire Z, Pelissolo A, Rochat T, Ibanez V. Personality, anxiety and mood traits in patients with sleep-related breathing disorders: effect of reduced daytime alertness. Sleep Med. 2002 Mar;3(2):139-45. doi: 10.1016/s1389-9457(01)00128-9.
- Background: PubMed 15941867Bixler EO, Vgontzas AN, Lin HM, Calhoun SL, Vela-Bueno A, Kales A. Excessive daytime sleepiness in a general population sample: the role of sleep apnea, age, obesity, diabetes, and depression. J Clin Endocrinol Metab. 2005 Aug;90(8):4510-5. doi: 10.1210/jc.2005-0035. Epub 2005 Jun 7.
- Background: PubMed 31082285Horenstein A, Morrison AS, Goldin P, Ten Brink M, Gross JJ, Heimberg RG. Sleep quality and treatment of social anxiety disorder. Anxiety Stress Coping. 2019 Jul;32(4):387-398. doi: 10.1080/10615806.2019.1617854. Epub 2019 May 13.
- Background: PubMed 12914662Snaith RP. The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. 2003 Aug 1;1:29. doi: 10.1186/1477-7525-1-29.
- 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.
Kyriakos Karkoulias, Prof. principal investigator
University Hospital of Patras, Greece
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Deprivation and Sleep Hygiene, run by Raivotech.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emmanouil Bakopoulos, MSc (+306945108313, info@raivotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the existence of depression and anxiety symptoms in the study population. (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06027047, which also lists 4 linked publications.
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 7 Sep 2023.