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

Anxiety Disorders Clinical Trial

— BASEL  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06027047
• Other study ID #: ROA101
• Status: Not yet recruiting
• Start date: September 1, 2023
• Est. completion date: January 15, 2024

Study information

• Verified date: August 2023
• Source: Raivotech
• Contact: Emmanouil Bakopoulos, MSc
• Phone: +306945108313
• Email: info[@]raivotech.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: January 15, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Raivotech

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

Snaith RP. The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. 2003 Aug 1;1:29. doi: 10.1186/1477-7525-1-29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the existence of depression and anxiety symptoms in the study population.	Comparison of HADS score with population standardized mean value.	2 weeks
Secondary	Correlation of depression and anxiety symptoms with Total sleep time (TST).	Total sleep time (TST).	2 weeks
Secondary	Correlation of depression and anxiety symptoms with Wake after sleep onset time (WASO).	Wake after sleep onset time (WASO).	2 weeks
Secondary	Correlation of depression and anxiety symptoms with Sleep Onset Latency (SOL).	Sleep Onset Latency (SOL).	2 weeks
Secondary	Correlation of depression and anxiety symptoms with Epworth Sleepiness Scale (ESS).	Epworth Sleepiness Scale (ESS).	2 weeks