Clinical trial NCT05300386: Wearable Devices to Assess Effects of Central Nervous Medications on Physical Conditions in Patients With Sleep Problems
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety Disorders
Sleep Apnea
Keywords: anxiety
sleep apnea
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 52
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Taiwanese

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.

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)

Primary outcomes:
measure: Change of the severity of anxiety measured by Beck Anxiety Inventory (BAI) across three points of the study
timeFrame: Assessed at the second, fourth, and twelfth weeks of the study
measure: Change of the severity of depression measured by Beck Depression Inventory (BDI) across three points of the study
timeFrame: Assessed at the second, fourth, and twelfth weeks of the study
measure: Change of the severity of daytime sleepiness measured by Epworth Sleepiness Scale (ESS) across three points of the study
timeFrame: Assessed at the second, fourth, and twelfth weeks of the study
measure: Change of sleep quality measured by Pittsburgh Sleep Quality Index (PSQI) across three points of the study
timeFrame: Assessed at the second, fourth, and twelfth weeks of the study
measure: Change of autonomic nervous system functioning measured by Heart rate variability (HRV) across three points of the study
timeFrame: Assessed at the second, fourth, and twelfth weeks of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
state: Neihu
Study officials:
affiliation: Tri-Service General Hospital
name: Tien-Yu Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: