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Clinical Trials/NCT06027047
NCT06027047
Not yet recruiting
Not Applicable

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

Raivotech0 sites50 target enrollmentStarted: September 1, 2023Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Raivotech
Enrollment
50
Primary Endpoint
To determine the existence of depression and anxiety symptoms in the study population.

Overview

Brief 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

  • History of alcohol or other substance abuse.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Correlation of depression and anxiety symptoms with Total sleep time (TST).(2 weeks)
  • Correlation of depression and anxiety symptoms with Wake after sleep onset time (WASO).(2 weeks)
  • Correlation of depression and anxiety symptoms with Sleep Onset Latency (SOL).(2 weeks)
  • Correlation of depression and anxiety symptoms with Epworth Sleepiness Scale (ESS).(2 weeks)

Investigators

Sponsor
Raivotech
Sponsor Class
Industry
Responsible Party
Sponsor

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