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Trial record 6 of 3030 for:    China Medicine University Hospital

Risk and Benefit Assessment of Hypnotic Agents for Sleep Disorders Among Elderly (RABA-HASDE)

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ClinicalTrials.gov Identifier: NCT02648776
Recruitment Status : Enrolling by invitation
First Posted : January 7, 2016
Last Update Posted : January 11, 2016
Sponsor:
Collaborator:
National Health Research Institutes, Taiwan
Information provided by (Responsible Party):
Hsiang-Wen Lin, China Medical University Hospital

Brief Summary:
The aims of this study are to (1) examine the medication use patterns of commonly prescribed hypnotics and the factors that were associated with the long-term and short-term use patterns among the elderly population in Taiwan; (2)investigate the associations of using hypnotics with the elderly patients' disease statuses, efficacy and safety, as well as its pharmacokinetic and pharmacogenetic characteristics;(3) determine the clinical, economic and humanistic outcomes of using hypnotics and the corresponding contributing factors for the elderly in Taiwan.

Condition or disease Intervention/treatment
Sleep Disorders Drug: Exposure to sedative-hypnotic drugs

Detailed Description:

Aging is associated with the changes in the sleep structure, continuity, and timing while it also affects the elderly's physiological and psychological health statuses. Despite the fact that hypnotics are beneficial for the short-term management of insomnia, it is inconclusive about the risk and benefit ratios of long-term use for the elderly. The objectives of this study are to (1)examine the medication use patterns of prescribed hypnotics and the factors that were associated with the use patterns among the elderly population; (2)investigate the associations of using prescribed hypnotics with the elderly patients' disease statuses, efficacy and safety, as well as their pharmacokinetic and pharmacogenetic characteristics;(3)determine the clinical, economic and humanistic outcomes and corresponding factors of using hypnotics for long-term and short-term use in Taiwanese elderly.

This proposed study is the second part of a larger project that consists of two main phases across four years. The first part will include a retrospective database analysis to examine the medication use patterns for sleep disorders and corresponding outcomes using three data sets. Elderly patients aged 65 or older and who received hypnotics for insomnia will be selected from Taiwan's National Health Insurance Research Database, National Health Interview Survey and China Medical University Hospital (CMUH) in-house databases. Focus will be placed on benzodiazepines (BZD) and BZD-receptor specific non-BZD agents (Z-drugs), but Chinese traditional medication used for insomnia will also be examined.

This study is the second part of the larger project. The investigators will conduct a longitudinal, prospective, observational cohort study over a period of two years. The focus of this study is the use of hypnotic BZD and Z-drugs on elderly insomnia patients. The study cohorts include elderly patients, aged 65 years or older, who have received services in the outpatient departments of China Medical University Hospital, Taichung, Taiwan, and who have been prescribed with a selected BZD or Z-drug for insomnia for at least one week. A control group cohort will also be recruited. Each recruited patient will be monitored and evaluated periodically for at least one year. Economic, clinical, and humanistic outcomes, as well as adherence to the hypnotics will be assessed and monitored. Safety and tolerability will be assessed by occurrence of adverse drug reactions. Pharmacokinetic properties and genotyping patterns will be also be evaluated using snapshot blood sampling after the 6th month of enrollment in the study. The clinical and humanistic outcomes measures will include changes in insomnia status, functional status changes, depression status, as well as over-all well-being using EuroQol 5D. Economic evaluation will compare total insurance and out-of-pocket expenses at baseline and at 12 months follow up.


Study Type : Observational
Estimated Enrollment : 1400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk and Benefit Assessment of Hypnotic Agents for Sleep Disorders Among Elderly; A Prospective Cohort Study at a Taiwanese Academic Medical Center
Study Start Date : January 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Disorders

Group/Cohort Intervention/treatment
Estazolam
Exposure to sedative-hypnotic drugs; Patients who have taken estazolam for at least one week before the first date of enrollment
Drug: Exposure to sedative-hypnotic drugs
These patients will have been prescribed a sedative-hypnotic drug for at least one week prior to enrollment.
Other Name: Medication Exposure

Lorazepam
Exposure to sedative-hypnotic drugs; Patients who have taken lorazepam for at least one week before the first date of enrollment
Drug: Exposure to sedative-hypnotic drugs
These patients will have been prescribed a sedative-hypnotic drug for at least one week prior to enrollment.
Other Name: Medication Exposure

Diazepam
Exposure to sedative-hypnotic drugs; Patients who have taken Diazepam for at least one week before the first date of enrollment
Drug: Exposure to sedative-hypnotic drugs
These patients will have been prescribed a sedative-hypnotic drug for at least one week prior to enrollment.
Other Name: Medication Exposure

Alprazolam
Exposure to sedative-hypnotic drugs; Patients who have taken Alprazolam for at least one week before the first date of enrollment
Drug: Exposure to sedative-hypnotic drugs
These patients will have been prescribed a sedative-hypnotic drug for at least one week prior to enrollment.
Other Name: Medication Exposure

Flunitrazepam
Exposure to sedative-hypnotic drugs; Patients who have taken Flunitrazepam for at least one week before the first date of enrollment
Drug: Exposure to sedative-hypnotic drugs
These patients will have been prescribed a sedative-hypnotic drug for at least one week prior to enrollment.
Other Name: Medication Exposure

Zolpidem
Exposure to sedative-hypnotic drugs; Patients who have taken Zolpidem for at least one week before the first date of enrollment
Drug: Exposure to sedative-hypnotic drugs
These patients will have been prescribed a sedative-hypnotic drug for at least one week prior to enrollment.
Other Name: Medication Exposure

Zopiclone
Exposure to sedative-hypnotic drugs; Patients who have taken Zopiclone for at least one week before the first date of enrollment
Drug: Exposure to sedative-hypnotic drugs
These patients will have been prescribed a sedative-hypnotic drug for at least one week prior to enrollment.
Other Name: Medication Exposure

Control Group
Patients not taking any of the included or any other anxiety-hypnotic agents



Primary Outcome Measures :
  1. Changes from baseline in sleep quality at 12 months [ Time Frame: after 12 months of enrollment ]
    Clinical outcome, measured by a Chinese version of the Pittsburgh Sleep Quality Index

  2. Number of participants with an occurrence of associated ADR [ Time Frame: after 12 months of enrollment ]
    Safety and tolerably, as measured by patients that experience falls, hip/limb fracture, cognitive impairment, etc. during the 12 months of enrollment


Secondary Outcome Measures :
  1. Snapshot measurement of plasma drug and drug metabolite concentrations [ Time Frame: after 6 months of enrollment ]
    Pharmacokinetic evaluation by determining the levels of drug and metabolite in the patients plasma after established use

  2. Snapshot measurement of urine drug and metabolite concentrations [ Time Frame: after 6 months of enrollment ]
    Pharmacokinetic evaluation by determining the levels of drug and metabolite in the patients plasma after established use -- and clearance after the sixth-month recruitments.

  3. Calculation of drug clearance using snapshot plasma and urine concentrations [ Time Frame: after 6 months of enrollment ]
    Pharmacokinetic evaluation by determining the patient's clearance of the drug after established use

  4. Proportion of patients with CYP3A5 mutations [ Time Frame: after 6 months of enrollment ]
    Pharmacogenetic evaluation and and genotyping of CYP3A5 enzyme for all enrolled patients with consent

  5. Changes from baseline in sleep quality at 6 months [ Time Frame: after 6 months of enrollment ]
    Clinical outcome, measured by a Chinese version of the Pittsburgh Sleep Quality Index

  6. Changes from baseline in Barthel Index at 6 months [ Time Frame: after 6 months of enrollment ]
    Clinical outcome, as a measure of independence, measured by Barthel Index

  7. Changes from baseline in Barthel Index at 12 months [ Time Frame: after 12 months of enrollment ]
    Clinical outcome, as a measure of independence, measured by Barthel Index

  8. Changes from baseline in IADL at 6 months [ Time Frame: after 6 months of enrollment ]
    Clinical outcome, as a measure of functional ability, measured by Instrumental Activities of Daily Living

  9. Changes from baseline in IADL at 12 months [ Time Frame: after 12 months of enrollment ]
    Clinical outcome, as a measure of functional ability, measured by Instrumental Activities of Daily Living

  10. Changes from baseline in EQ-5D-5L & EQ-5D-VAS at 6 months [ Time Frame: after 6 months of enrollment ]
    Changes in humanistic variables, as measured by the EuroQol 5D tool

  11. Changes from baseline in EQ-5D-5L & EQ-5D-VAS at 12 months [ Time Frame: after 12 months of enrollment ]
    Changes in humanistic variables, as measured by the EuroQol 5D tool

  12. Changes from baseline in MMAS-8 after 6 months [ Time Frame: after 6 months of enrollment ]
    Changes in medication adherence, as measured by the Morisky Medication Adherence

  13. Changes from baseline in MMAS-8 after 12 months [ Time Frame: after 12 months of enrollment ]
    Changes in medication adherence, as measured by the Morisky Medication Adherence

  14. Change from baseline in economic healthcare costs using NHI and out-of-pocket expenses at 12months [ Time Frame: At 12 months after enrollment ]
    NHI covered costs for inpatient and outpatient care taken from NHI data for the twelve months prior to enrollment, compared to the 12 months during enrollment. Added with patients' out of pocket expenses on health care.

  15. Changes from baseline in insomnia at 6 months [ Time Frame: After 6 months of enrollment ]
    Clinical outcome, measured by a Chinese version of the Athens Insomnia Scale

  16. Changes from baseline in insomnia at 12 months [ Time Frame: After 12 months of enrollment ]
    Clinical outcome, measured by a Chinese version of the Athens Insomnia Scale


Biospecimen Retention:   Samples With DNA
A single set of blood and urine samples taken in cohorts taking sedative-hypnotic medications, used to evaluate pharmacokinetic and pharmcogenetic parameters.


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Longitudinal prospective observational cohort study

Elderly patients receiving regular outpatient services at China Medical University Hospital

Criteria
  • Inclusion criteria

    1. Patients who have received services in the outpatient departments in CMUH for at least six months persistently before the recruitment,
    2. who are diagnosed with any types of sleep disorders within the outpatient medical records, using ICD-9 codes to identify.
    3. who have been prescribed, for at least one week before the index date of observation, with one of the selected BZD or Z-drugs: estazolam, lorazepam, diazepam, alprazolam, flunitrazepam, zolpidem or zopiclone.
    4. who agree to participate in this observation study and have signed informed consent
  • Exclusion criteria

    1. Those elderly patients who were diagnosed with cancers, seizures, specific psychiatric disorders (e.g., dementia, schizophrenia, panic disorder, alcohol withdrawal syndrome) and neurological disorders (e.g., Parkinson) in the baseline and during observation period

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02648776


Locations
Taiwan
China Medical University Hospital
Taichung, Taiwan
Sponsors and Collaborators
China Medical University Hospital
National Health Research Institutes, Taiwan
Investigators
Principal Investigator: Hsiang-Wen Lin, PhD Pharmacist, Associate Professor

Responsible Party: Hsiang-Wen Lin, Associate Professor, China Medical University Hospital
ClinicalTrials.gov Identifier: NCT02648776     History of Changes
Other Study ID Numbers: DMR101-IRB1-083
First Posted: January 7, 2016    Key Record Dates
Last Update Posted: January 11, 2016
Last Verified: January 2016

Keywords provided by Hsiang-Wen Lin, China Medical University Hospital:
hypnotic agents
sleep disorders
elderly

Additional relevant MeSH terms:
Physiological Effects of Drugs
Psychotropic Drugs
Disease
Sleep Wake Disorders
Parasomnias
Pathologic Processes
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Hypnotics and Sedatives
Alprazolam
Flunitrazepam
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action