NCT05300386

Wearable Devices to Assess Effects of Central Nervous Medications on Physical Conditions in Patients With Sleep Problems

Using Wearable Devices to Investigate the Basic Physical Conditions of Patients With Sleep Problems and the Physical Effects During Sleep on Patients Who Use the Central Nervous Medications for Sleep Problems

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 52 (actual)
• Sponsor: Tri-Service General Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Generalized anxiety disorder (GAD) and obstructive sleep apnea (OSA) are two common diseases and share similar symptoms such as anxiety, poor attention, and poor sleep quality. However, the evidence toward the association between GAD and OSA is limited. The current study aims to use wearable devices to detect comorbid OSA in newly diagnosed patients with GAD and observe the treatment response and difference in automatic nervous function in GAD and GAD/OSA groups.

Detailed description

Background: The symptoms of a generalized anxiety disorder (GAD) included excessive anxiety, restlessness, fatigue, poor concentration, irritability, and poor sleep quality. GAD is frequently combined with depressive disorder and autonomic dysfunction and is one of the most prevalent psychiatric disorders in a psychiatric clinic. However, many of the symptoms of GAD are like the symptoms of obstructive sleep apnea (OSA), such as daytime fatigue, poor attention, and poor sleep quality. In addition, patients with OSA are easily comorbid with symptoms of anxiety and depression in retrospective studies. Nevertheless, there is limited data present on the comorbid of OSA in newly diagnosed patients with GAD. It is important to realize the comorbidities between OSA and GAD. Many of the benzodiazepines for GAD during sleep may worsen the severity of sleep apnea. Therefore, realizing the relationship between GAD and OSA is important for clinicians. Question/Hypothesis: We hypothesize that patients with newly diagnosed GAD have a high ratio of OSA comorbidity and those with both GAD and OSA have worse severity of anxiety symptoms and heart rate variability. Specific Aims: Current study aims to investigate 1) the prevalence of OSA in newly diagnosed patients with GAD; 2) the difference of heart rate variability and baseline characteristics between newly diagnosed patients with GAD and GAD with OSA; 3) the difference of antidepressant treatment response between newly diagnosed patients with GAD and GAD with OSA. Experimental design: This study aims to enroll 80 participants with GAD, 40 patients with newly diagnosed GAD and 40 newly diagnosed GAD comorbid with OSA by using a home sleep apnea test and used validated cloud-computing sleep apnea screening system. In addition, we would investigate the difference between baseline characteristics and heart rate variability among healthy participants, GAD, and GAD comorbid OSA. In addition, we also evaluate the difference in antidepressant treatment effect on GAD patients with and without OSA on week 2, week 4, and week 12.

Conditions

• Anxiety Disorders
• Sleep Apnea

Interventions

Type	Name	Description
DRUG	Escitalopram	We use Escitalopram 5\~10 mg for two groups to observe the impact of sleep apnea on the treatment of generalized anxiety disorder

Timeline

• Start date: 2018-05-30
• Primary completion: 2021-05-29
• Completion: 2022-01-31
• First posted: 2022-03-29
• Last updated: 2022-03-29

Locations

1 site across 1 country: Taiwan