Sleep DisordersRABA-HASDENCT02648776
Risk and Benefit Assessment of Hypnotic Agents for Sleep Disorders Among Elderly
An observational study of Sleep Disorders, run by China Medical University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorders
- What is being tested?
- Exposure to sedative-hypnotic drugs
- How many people
- 1,400 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2016to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Longitudinal prospective observational cohort study Elderly patients receiving regular outpatient services at China Medical University Hospital
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk and Benefit Assessment of Hypnotic Agents for Sleep Disorders Among Elderly; A Prospective Cohort Study at a Taiwanese Academic Medical Center
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.
Read the 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.
- Conditions
- Sleep Disorders
- Being tested
- Exposure to sedative-hypnotic drugs
- Keywords
- hypnotic agents, sleep disorders, elderly
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to sedative-hypnotic drugsDrug
Also called Medication Exposure
These patients will have been prescribed a sedative-hypnotic drug for at least one week prior to enrollment.
| Study group | Role | What they receive |
|---|---|---|
| Estazolam | Exposure to sedative-hypnotic drugs; Patients who have taken estazolam for at least one week before the first date of enrollment Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: Exposure to sedative-hypnotic drugs | |
| Control Group | Patients not taking any of the included or any other anxiety-hypnotic agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in sleep quality at 12 months
Clinical outcome, measured by a Chinese version of the Pittsburgh Sleep Quality Index
Measured: 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
Measured: after 12 months of enrollment
Secondary outcomes (16)
Snapshot measurement of plasma drug and drug metabolite concentrations
Pharmacokinetic evaluation by determining the levels of drug and metabolite in the patients plasma after established use
Measured: after 6 months of enrollment
Snapshot measurement of urine drug and metabolite concentrations
Pharmacokinetic evaluation by determining the levels of drug and metabolite in the patients plasma after established use -- and clearance after the sixth-month recruitments.
Measured: after 6 months of enrollment
Calculation of drug clearance using snapshot plasma and urine concentrations
Pharmacokinetic evaluation by determining the patient's clearance of the drug after established use
Measured: after 6 months of enrollment
Proportion of patients with CYP3A5 mutations
Pharmacogenetic evaluation and and genotyping of CYP3A5 enzyme for all enrolled patients with consent
Measured: after 6 months of enrollment
Changes from baseline in sleep quality at 6 months
Clinical outcome, measured by a Chinese version of the Pittsburgh Sleep Quality Index
Measured: after 6 months of enrollment
Changes from baseline in Barthel Index at 6 months
Clinical outcome, as a measure of independence, measured by Barthel Index
Measured: after 6 months of enrollment
Changes from baseline in Barthel Index at 12 months
Clinical outcome, as a measure of independence, measured by Barthel Index
Measured: after 12 months of enrollment
Changes from baseline in IADL at 6 months
Clinical outcome, as a measure of functional ability, measured by Instrumental Activities of Daily Living
Measured: after 6 months of enrollment
Changes from baseline in IADL at 12 months
Clinical outcome, as a measure of functional ability, measured by Instrumental Activities of Daily Living
Measured: after 12 months of enrollment
Changes from baseline in EQ-5D-5L & EQ-5D-VAS at 6 months
Changes in humanistic variables, as measured by the EuroQol 5D tool
Measured: after 6 months of enrollment
Changes from baseline in EQ-5D-5L & EQ-5D-VAS at 12 months
Changes in humanistic variables, as measured by the EuroQol 5D tool
Measured: after 12 months of enrollment
Changes from baseline in MMAS-8 after 6 months
Changes in medication adherence, as measured by the Morisky Medication Adherence
Measured: after 6 months of enrollment
Changes from baseline in MMAS-8 after 12 months
Changes in medication adherence, as measured by the Morisky Medication Adherence
Measured: after 12 months of enrollment
Change from baseline in economic healthcare costs using NHI and out-of-pocket expenses at 12months
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.
Measured: At 12 months after enrollment
Changes from baseline in insomnia at 6 months
Clinical outcome, measured by a Chinese version of the Athens Insomnia Scale
Measured: After 6 months of enrollment
Changes from baseline in insomnia at 12 months
Clinical outcome, measured by a Chinese version of the Athens Insomnia Scale
Measured: After 12 months of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisordersStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Responsible party
- Principal investigator, Hsiang-Wen Lin, China Medical University Hospital
- Investigators
- Hsiang-Wen Lin, PhD, Principal investigator, Pharmacist, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02648776
- Sponsor's protocol ID
- DMR101-IRB1-083
- Acronym
- RABA-HASDE
- Status last verified
- Jan 2016
- First submitted
- 24 Mar 2015
- Last updated
- 11 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk and Benefit Assessment of Hypnotic Agents for Sleep Disorders Among Elderly; A Prospective Cohort Study at a Taiwanese Academic Medical Center
- ClinicalTrials.gov ID
- NCT02648776
- Acronym / sponsor ID
- RABA-HASDE / DMR101-IRB1-083
- Conditions
- Sleep Disorders
- Keywords
- hypnotic agents, sleep disorders, elderly
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Study start
- Jan 2016
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 7 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Estazolam | – | Drug: Exposure to sedative-hypnotic drugsExposure to sedative-hypnotic drugs; Patients who have taken estazolam for at least one week before the first date of enrollment |
| Lorazepam | – | Drug: Exposure to sedative-hypnotic drugsExposure to sedative-hypnotic drugs; Patients who have taken lorazepam for at least one week before the first date of enrollment |
| Diazepam | – | Drug: Exposure to sedative-hypnotic drugsExposure to sedative-hypnotic drugs; Patients who have taken Diazepam for at least one week before the first date of enrollment |
| Alprazolam | – | Drug: Exposure to sedative-hypnotic drugsExposure to sedative-hypnotic drugs; Patients who have taken Alprazolam for at least one week before the first date of enrollment |
| Flunitrazepam | – | Drug: Exposure to sedative-hypnotic drugsExposure to sedative-hypnotic drugs; Patients who have taken Flunitrazepam for at least one week before the first date of enrollment |
| Zolpidem | – | Drug: Exposure to sedative-hypnotic drugsExposure to sedative-hypnotic drugs; Patients who have taken Zolpidem for at least one week before the first date of enrollment |
| Zopiclone | – | Drug: Exposure to sedative-hypnotic drugsExposure to sedative-hypnotic drugs; Patients who have taken Zopiclone for at least one week before the first date of enrollment |
| Control Group | – | –Patients not taking any of the included or any other anxiety-hypnotic agents |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Longitudinal prospective observational cohort study Elderly patients receiving regular outpatient services at China Medical University Hospital
Key inclusion criteria (4 listed)
Key exclusion criteria (1 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure to sedative-hypnotic drugsAlso: Medication ExposureThese patients will have been prescribed a sedative-hypnotic drug for at least one week prior to enrollment. | Drug | Alprazolam, Diazepam, Estazolam, Flunitrazepam, Lorazepam, Zolpidem, Zopiclone |
Primary outcome
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
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
16 secondary outcomes
Snapshot measurement of plasma drug and drug metabolite concentrations
Time frame: after 6 months of enrollment
Snapshot measurement of urine drug and metabolite concentrations
Time frame: after 6 months of enrollment
Calculation of drug clearance using snapshot plasma and urine concentrations
Time frame: after 6 months of enrollment
Proportion of patients with CYP3A5 mutations
Time frame: after 6 months of enrollment
Changes from baseline in sleep quality at 6 months
Time frame: after 6 months of enrollment
Changes from baseline in Barthel Index at 6 months
Time frame: after 6 months of enrollment
Changes from baseline in Barthel Index at 12 months
Time frame: after 12 months of enrollment
Changes from baseline in IADL at 6 months
Time frame: after 6 months of enrollment
Changes from baseline in IADL at 12 months
Time frame: after 12 months of enrollment
Changes from baseline in EQ-5D-5L & EQ-5D-VAS at 6 months
Time frame: after 6 months of enrollment
Changes from baseline in EQ-5D-5L & EQ-5D-VAS at 12 months
Time frame: after 12 months of enrollment
Changes from baseline in MMAS-8 after 6 months
Time frame: after 6 months of enrollment
Changes from baseline in MMAS-8 after 12 months
Time frame: after 12 months of enrollment
Change from baseline in economic healthcare costs using NHI and out-of-pocket expenses at 12months
Time frame: At 12 months after enrollment
Changes from baseline in insomnia at 6 months
Time frame: After 6 months of enrollment
Changes from baseline in insomnia at 12 months
Time frame: After 12 months of enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsiang-Wen Lin, PhD principal investigator
Pharmacist, Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Disorders, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in sleep quality at 12 months (time frame: after 12 months of enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2016.