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

Sponsor

Raivotech (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06027047

Collaborator

(none)

Enrollment

4.5

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Deprivation Sleep Hygiene Sleepiness Sleep Driving Depression, Anxiety Anxiety Disorders Depressive Symptoms

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Jan 15, 2024

Outcome Measures

Primary Outcome Measures

To determine the existence of depression and anxiety symptoms in the study population. [2 weeks]
Comparison of HADS score with population standardized mean value.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

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.