Clinical trial NCT06027047: Breakthrough Anxiety and Sleep Evaluation Using Linked Devices and Smartphone Application Onar (BASEL)
Official title: Breakthrough Anxiety and Sleep Evaluation Using Linked Devices and Smartphone Application Onar (BASEL)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Sleep Deprivation
Sleep Hygiene
Sleepiness
Sleep Driving
Depression, Anxiety
Anxiety Disorders
Depressive Symptoms
Keywords: smartphone
wearables
app
sleep
anxiety
depression
Lead sponsor: Raivotech
Sponsor class: INDUSTRY
First posted: 2023-09-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: To determine the existence of depression and anxiety symptoms in the study population.
timeFrame: 2 weeks
Secondary outcomes:
measure: Correlation of depression and anxiety symptoms with Total sleep time (TST).
timeFrame: 2 weeks
measure: Correlation of depression and anxiety symptoms with Wake after sleep onset time (WASO).
timeFrame: 2 weeks
measure: Correlation of depression and anxiety symptoms with Sleep Onset Latency (SOL).
timeFrame: 2 weeks
measure: Correlation of depression and anxiety symptoms with Epworth Sleepiness Scale (ESS).
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital of Patras, Greece
name: Kyriakos Karkoulias, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.