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

NCT06027047 | Unknown DMC

• 1 other identifier: ROA101
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

smartphone; wearables; app; sleep; anxiety; depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• History of alcohol or other substance abuse.

Sponsors & Collaborators

• Raivotech: lead

Related Publications (4)

• 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.

  PMID: 14592233 BACKGROUND

• 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.

  PMID: 15941867 BACKGROUND

• 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.

  PMID: 31082285 BACKGROUND

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

  PMID: 12914662 BACKGROUND

MeSH Terms

Conditions

Sleep Deprivation; Sleep Hygiene; Sleepiness; Depression; Anxiety Disorders; Alzheimer Disease

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Health Behavior; Behavior; Behavioral Symptoms; Dementia; Brain Diseases; Central Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders

Study Officials

• Kyriakos Karkoulias, Prof.

  University Hospital of Patras, Greece

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emmanouil Bakopoulos, MSc

CONTACT

+306945108313; info@raivotech.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: September 7, 2023
• Study Start: September 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: January 15, 2024
• Last Updated: September 7, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share