Risk and Benefit Assessment of Hypnotic Agents for Sleep Disorders Among Elderly

NCT02648776 | Unknown

• 1 other identifier: DMR101-IRB1-083
• Study Type: observational
• Target: 1,400
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disorders

Keywords

hypnotic agents; sleep disorders; elderly

Outcome Measures

Primary Outcomes (2)

• Changes from baseline in sleep quality at 12 months

  Clinical outcome, measured by a Chinese version of the Pittsburgh Sleep Quality Index

  after 12 months of enrollment

• Number of participants with an occurrence of associated ADR

  Safety and tolerably, as measured by patients that experience falls, hip/limb fracture, cognitive impairment, etc. during the 12 months of enrollment

  after 12 months of enrollment

Secondary Outcomes (16)

• Snapshot measurement of plasma drug and drug metabolite concentrations

  after 6 months of enrollment

• Snapshot measurement of urine drug and metabolite concentrations

  after 6 months of enrollment

• Calculation of drug clearance using snapshot plasma and urine concentrations

  after 6 months of enrollment

• Proportion of patients with CYP3A5 mutations

  after 6 months of enrollment

• Changes from baseline in sleep quality at 6 months

  after 6 months of enrollment

Study Arms (8)

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

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

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

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

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

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

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

Control Group

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

Interventions

Exposure to sedative-hypnotic drugs DRUG

These patients will have been prescribed a sedative-hypnotic drug for at least one week prior to enrollment.

Also known as: Medication Exposure

Alprazolam; Diazepam; Estazolam; Flunitrazepam; Lorazepam; Zolpidem; Zopiclone

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Longitudinal prospective observational cohort study Elderly patients receiving regular outpatient services at China Medical University Hospital

You may qualify if:

• Patients who have received services in the outpatient departments in CMUH for at least six months persistently before the recruitment,
• who are diagnosed with any types of sleep disorders within the outpatient medical records, using ICD-9 codes to identify.
• 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.
• who agree to participate in this observation study and have signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• China Medical University Hospital: lead
• National Health Research Institutes, Taiwan: collaborator

Study Sites (1)

China Medical University Hospital

Taichung, Taiwan

Location

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.

MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Hsiang-Wen Lin, PhD

  Pharmacist, Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 24, 2015
• First Posted: January 7, 2016
• Study Start: January 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 11, 2016

Record last verified: 2016-01

Locations

TW (1)