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

NCT ID: NCT05300386

Last Updated: 2022-03-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 52 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-05-30
• Study Completion Date: 2022-01-31

Brief 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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

generalized anxiety with oxygen desaturation index less than 5

we enrolled patients with generalized anxiety with oxygen desaturation index of less than 5 and examed the basic physical conditions and the effectiveness of antidepressant treatment.

Escitalopram

Intervention Type: DRUG

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

generalized anxiety with oxygen desaturation index more than 5

we enrolled patients with generalized anxiety with oxygen desaturation index of more than 5 and examed the basic physical conditions and the effectiveness of antidepressant treatment.

Escitalopram

Intervention Type: DRUG

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

Interventions

Escitalopram

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Diagnosis as drug-naïve GAD with an unexpected diagnosis of OSA
• Go to bed between 8:30 pm to midnight
• Have a BMI between 18-34
• Agree to sign an informed consent and use wearable devices to detect sleep

Exclusion Criteria

• Pregnancy and pacemaker implantation
• Shift workers or travel to 3 different timelines 7 days before study entry day
• Diabetes, cancer, neuropathy, any cardiovascular diseases that affect HRV
• Alcohol, illegal drugs, tobacco use
• Currently use medications that affect the HRV (e.g., antipsychotics, anticholinergics, antidepressants, and anticonvulsants)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tri-Service General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tien-Yu Chen

Visiting Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tien-Yu Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Tri-Service General Hospital

Locations

Tri-Service General Hospital

Taipei, Neihu, Taiwan

Countries

Taiwan

Other Identifiers

2-107-05-046

Identifier Type: -

Identifier Source: org_study_id