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

18 de marzo de 2022 actualizado por: Tien-Yu Chen, Tri-Service General Hospital

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

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.

Descripción general del estudio

Estado

Terminado

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Actual)

52

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Neihu
      • Taipei, Neihu, Taiwán, 114
        • Tri-Service General Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

20 años a 85 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

Taiwanese

Descripción

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)

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
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.
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.
We use Escitalopram 5~10 mg for two groups to observe the impact of sleep apnea on the treatment of generalized anxiety disorder

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change of the severity of anxiety measured by Beck Anxiety Inventory (BAI) across three points of the study
Periodo de tiempo: Assessed at the second, fourth, and twelfth weeks of the study

The Beck Anxiety Inventory (BAI) is a 21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety in adolescents and adults ages 17 and older. The questions used in this measure ask about common symptoms of anxiety that the subject has had during the past week (including the day you take it) (such as numbness and tingling, sweating not due to heat, and fear of the worst happening). The BAI contains 21 questions, each answer being scored on a scale value of 0 (not at all) to 3 (severely). Higher total scores indicate more severe anxiety symptoms.

The standardized cutoffs are:

  • 0-7: Minimal
  • 8-15: Mild
  • 16-25: Moderate
  • 26-63: Severe
Assessed at the second, fourth, and twelfth weeks of the study
Change of the severity of depression measured by Beck Depression Inventory (BDI) across three points of the study
Periodo de tiempo: Assessed at the second, fourth, and twelfth weeks of the study

The Beck Depression Inventory (BDI) is a 21-question multiple-choice self-report inventory, one of the most widely used psychometric tests for measuring the severity of depression. The BDI is designed for individuals aged 13 and over, and is composed of items relating to symptoms of depression such as hopelessness and irritability, cognitions such as guilt or feelings of being punished, as well as physical symptoms such as fatigue, weight loss, and lack of interest in sex. The BDI contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms.

The standardized cutoffs are:

  • 0-13: minimal depression
  • 14-19: mild depression
  • 20-28: moderate depression
  • 29-63: severe depression.
Assessed at the second, fourth, and twelfth weeks of the study
Change of the severity of daytime sleepiness measured by Epworth Sleepiness Scale (ESS) across three points of the study
Periodo de tiempo: Assessed at the second, fourth, and twelfth weeks of the study

The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. Most people engage in those activities at least occasionally, although not necessarily every day. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'.

In general ESS scores can be interpreted as follows:

  • 0-5 Lower Normal Daytime Sleepiness
  • 6-10 Higher Normal Daytime Sleepiness
  • 11-12 Mild Excessive Daytime Sleepiness
  • 13-15 Moderate Excessive Daytime Sleepiness
  • 16-24 Severe Excessive Daytime Sleepiness
Assessed at the second, fourth, and twelfth weeks of the study
Change of sleep quality measured by Pittsburgh Sleep Quality Index (PSQI) across three points of the study
Periodo de tiempo: Assessed at the second, fourth, and twelfth weeks of the study
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete. The PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. A final score >5 be considered as a significant sleep disturbance.
Assessed at the second, fourth, and twelfth weeks of the study
Change of autonomic nervous system functioning measured by Heart rate variability (HRV) across three points of the study
Periodo de tiempo: Assessed at the second, fourth, and twelfth weeks of the study
Heart rate variability (HRV) consists of changes in the time intervals between consecutive heartbeats called interbeat intervals (IBIs). HRV indexes neurocardiac function and is generated by heart-brain interactions and dynamic non-linear autonomic nervous system processes. HRV reflects regulation of autonomic balance, blood pressure (BP), gas exchange, gut, heart, and vascular tone, which refers to the diameter of the blood vessels that regulate BP, and possibly facial muscles. HRV can be analyzed through time-domain, frequency-domain, and non-linear metrics. Time-domain indices quantify the amount of HRV observed during monitoring periods that may range from ~2 min to 24 h. Frequency-domain values calculate the absolute or relative amount of signal energy within component bands. Non-linear measurements quantify the unpredictability and complexity of a series of IBIs.
Assessed at the second, fourth, and twelfth weeks of the study

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Tien-Yu Chen, MD, Tri-Service General Hospital

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

30 de mayo de 2018

Finalización primaria (Actual)

29 de mayo de 2021

Finalización del estudio (Actual)

31 de enero de 2022

Fechas de registro del estudio

Enviado por primera vez

26 de febrero de 2022

Primero enviado que cumplió con los criterios de control de calidad

18 de marzo de 2022

Publicado por primera vez (Actual)

29 de marzo de 2022

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

29 de marzo de 2022

Última actualización enviada que cumplió con los criterios de control de calidad

18 de marzo de 2022

Última verificación

1 de marzo de 2022

Más información

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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