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

Not yet recruiting

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

• Registration Number: NCT06027047
• Lead Sponsor: Raivotech

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-08-30
• Study First Submitted QC: 2023-08-30
• Last Update Submitted: 2023-08-30
• Study Start: 2023-09-01
• Study First Posted: 2023-09-07
• Last Update Posted: 2023-09-07
• Primary Completion: 2023-12-31
• Study Completion: 2024-01-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).