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

18 maart 2022 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

52

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

20 jaar tot 85 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Taiwanese

Beschrijving

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)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change of the severity of anxiety measured by Beck Anxiety Inventory (BAI) across three points of the study
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

30 mei 2018

Primaire voltooiing (Werkelijk)

29 mei 2021

Studie voltooiing (Werkelijk)

31 januari 2022

Studieregistratiedata

Eerst ingediend

26 februari 2022

Eerst ingediend dat voldeed aan de QC-criteria

18 maart 2022

Eerst geplaatst (Werkelijk)

29 maart 2022

Updates van studierecords

Laatste update geplaatst (Werkelijk)

29 maart 2022

Laatste update ingediend die voldeed aan QC-criteria

18 maart 2022

Laatst geverifieerd

1 maart 2022

Meer informatie

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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