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Not yet recruitingNCT06027047BASELUpdated Sep 7, 2023

Breakthrough Anxiety and Sleep Evaluation Using Linked Devices and Smartphone Application Onar (BASEL)

An observational study in Sleep Deprivation, Sleep Hygiene and Sleepiness, sponsored by Raivotech. Not yet recruiting. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-07.

Sponsored by Raivotech · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 10 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 60 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Sleep Deprivation
  • Sleep Hygiene
  • Sleepiness
  • Sleep Driving
  • Depression, Anxiety
  • Anxiety Disorders
  • Depressive Symptoms

Keywords

  • smartphone
  • wearables
  • app
  • sleep
  • anxiety
  • depression
03

In context

Sleep Deprivation

314 studies on the registry are indexed under Sleep Deprivation; 59 are open to participants now.

This study's planned enrollment of 50 is close to the median of 53 across 52 observational studies indexed under Sleep Deprivation.

Browse Sleep Deprivation studies →

Lead sponsor

This is the only study on the registry with Raivotech as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • History of alcohol or other substance abuse.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. To determine the existence of depression and anxiety symptoms in the study population.

    Comparison of HADS score with population standardized mean value.

    Time frame: 2 weeks

Secondary outcomes

  1. Correlation of depression and anxiety symptoms with Total sleep time (TST).

    Total sleep time (TST).

    Time frame: 2 weeks

  2. Correlation of depression and anxiety symptoms with Wake after sleep onset time (WASO).

    Wake after sleep onset time (WASO).

    Time frame: 2 weeks

  3. Correlation of depression and anxiety symptoms with Sleep Onset Latency (SOL).

    Sleep Onset Latency (SOL).

    Time frame: 2 weeks

  4. Correlation of depression and anxiety symptoms with Epworth Sleepiness Scale (ESS).

    Epworth Sleepiness Scale (ESS).

    Time frame: 2 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

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 14592233 ↗
  • Bixler 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 15941867 ↗
  • Horenstein 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 31082285 ↗
  • Snaith 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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2023; primary completion for Dec 2023, 3 months later.

Of 25 observational studies under Sleep Deprivation, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 58. This study's planned 3 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 30, 2023
First posted
Sep 7, 2023
StartEst.
Sep 1, 2023
Primary completionEst.
Dec 31, 2023
CompletionEst.
Jan 15, 2024
Last update
Sep 7, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06027047
Lead sponsor
Raivotech
Responsible party
Sponsor
First posted
Sep 7, 2023
Start date
Sep 1, 2023 (estimated)
Primary completion
Dec 31, 2023 (estimated)
Completion
Jan 15, 2024 (estimated)
Last update
Sep 7, 2023

Study contacts

Emmanouil Bakopoulos, MSc
Contact
info@raivotech.com
+306945108313
Kyriakos Karkoulias, Prof.
principal investigator · University Hospital of Patras, Greece

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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