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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
Neihu
-
Taipei、Neihu、台湾、114
- Tri-Service General Hospital
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change of the severity of anxiety measured by Beck Anxiety Inventory (BAI) across three points of the study
時間枠：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:
|
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
時間枠：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:
|
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
時間枠：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:
|
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
時間枠：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
時間枠：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
|
協力者と研究者
捜査官
- 主任研究者：Tien-Yu Chen, MD、Tri-Service General Hospital
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。