Irregular Sleep Wake Rhythm DisorderNCT04300569
A Study to Determine the Signs and Symptoms That Impact Daily Life of Participants With Irregular Sleep-Wake Rhythm Disorder
An observational study of Irregular Sleep Wake Rhythm Disorder, run by Eisai Inc. at 6 sites in United States.
Trial summary
The primary purpose of this study is to determine the signs and symptoms of irregular sleep-wake rhythm disorder (ISWRD) that are important to patients and caregivers of patients with Alzheimer's disease dementia (AD-D), AD-D with cerebrovascular disease (CVD), and/or vascular dementia (VaD) and ISWRD, and to draft an… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Irregular Sleep Wake Rhythm Disorder
- What is being tested?
- Non-interventional
- How many people
- 37 participants
- Where
- 6 sitesUnited States
- Study dates
- 9 Jul 2020to 7 Sep 2020
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with AD-D, AD-D with CVD and/or VaD and ISWRD and caregivers of patients.
Who may be able to join
- Patient Participants
- Age 60 to 90 years at time of informed consent
- Documentation of diagnosis of AD-D on the basis of the clinical criteria of the National Institute on Aging/Alzheimer's Association (NIA-AA) diagnostic guidelines and/or VaD on the basis of the National Institute of Neurological Disorders and Stroke (NINDS) and the Association Internationale pour la Recherche et l'Enseignement en Neurosciences (AIREN) criteria, and AD-D with CVD on the basis of NINDS-AIREN criteria
- If the Mini Mental State Examination (MMSE) is conducted (mandatory for clinic visits only) or is available within the past 3 months (all patient participants), MMSE 10 to 26. Note: For all patient participants who undergo a clinic visit, an MMSE must be conducted unless this has been assessed within the past 3 months and the score is available. No MMSE will be conducted during telephone visits, but if a recent MMSE is available, that is, within the past 3 months, that MMSE must be assessed for eligibility.
- Meets criteria for Circadian Rhythm Sleep Disorder, Irregular Sleep-Wake Type (Diagnostic and Statistical Manual of Mental Disorders - 5th edition [DSM-5]) and the 10th revision of the International Classification of Diseases (ICD-10), as follows: Complaint by the patient or caregiver that the patient has difficulty sleeping during the night and/or has excessive daytime sleepiness associated with multiple irregular sleep bouts during a 24-hour period
- Frequency of complaint of sleep and wake fragmentation greater than equal to (>=) 3 days per Week
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- Duration of complaint of sleep and wake fragmentation >=3 Months
- If currently taking medications that are used to treat behaviors associated with ISWRD, such as antipsychotic medications or trazodone, the dose must be stable for at least 1 Month
- Has a caregiver who is also a participant in this study and who meets the eligibility criteria below
- Is able to speak and understand English or Spanish at a level sufficient to participate in the study interviews, according to the investigator's judgement
- Caregivers
- Age 18 years or older at the time of consent
- Where the patient is not a study participant (that is, is a non-interviewed patient): The caregiver currently lives with a patient who meets the following criteria:
- Has a documented diagnosis of AD-D on the basis of the NIA-AA diagnostic guidelines and/or VaD per NINDS-AIREN criteria
- Meets criteria for Circadian Rhythm Sleep Disorder, Irregular Sleep-Wake Type (DSM-5) and the 10th revision of the International Classification of Diseases (ICD-10), as follows: Complaint by the patient or caregiver that the patient has difficulty sleeping during the night and/or has excessive daytime sleepiness associated with multiple irregular sleep bouts during a 24-hour period
- Is able and willing to provide informed consent or assent.
- If the MMSE is conducted for the non-interviewed patient (mandatory for clinic visits only) or has been assessed during the past 3 months (all non-interviewed patients), MMSE 10 to 26 Note: For all non-interviewed patients who undergo a clinic visit, the MMSE must be checked for eligibility. The MMSE will be conducted at the clinic visit unless this has been assessed within the past 3 months and the score is available. No MMSE will be conducted during telephone visits, but if a recent MMSE is available,that is, within the past 3 months, that MMSE must be assessed for eligibility.)
- Is sufficiently familiar (as determined by the investigator) with the patient participant or non-interviewed patient to provide accurate data. The caregiver must share the patient's domicile for an average of at least 5 days and 5 overnights per week for at least the past 3 months
- Able to speak and understand English or Spanish at a level sufficient to participate in the study interviews, according to the investigator's judgement
- Willing to have the interview audio recorded
Who cannot join
- Patient Participants
- A diagnosis of a Lewy body dementia (including Parkinson's disease dementia or dementia with Lewy bodies)
- A diagnosis of moderate or severe obstructive sleep apnea (OSA), or current use of continuous positive airway pressure (CPAP) even if mild OSA, restless legs syndrome or any other disorder except ISWRD that is likely to impact sleep and interfere with the assessment of ISWRD in the opinion of the investigator
- Caregivers
- The person for whom they care is a non-interviewed patient with any of the following:
- A diagnosis of OSA, restless legs syndrome or any other disorder except ISWRD that is likely to impact sleep and interfere with the assessment of ISWRD in the opinion of the investigator
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- A diagnosis of a Lewy body dementia (including Parkinson's disease dementia or dementia with Lewy bodies)
- Evidence of current clinically significant disease (example, cardiac, respiratory, gastrointestinal, renal disease) or any psychiatric disorder other than dementia, that in the opinion of the clinic site investigator could interfere with the assessment of ISWRD
- History of drug or alcohol dependency or abuse within approximately the last 2 years
- Psychotic disorder(s) or unstable recurrent affective disorder(s) as evident by use of antipsychotic medications within approximately the last 2 years
- History of drug or alcohol dependency or abuse within approximately the last 2 years
- Current regular use (greater than [>]2) times per week) of medication prescribed to treat insomnia (either approved or off-label)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
ATP Clinical Research
Costa Mesa, California, 92626
Miami Jewish Health Systems
Miami, Florida, 33137
Panax Clinical Research
Miami Lakes, Florida, 33014
Pacific Research Network Inc
San Diego, California, 92103
Abington Neurologic Associate
Willow Grove, Pennsylvania, 19090
About this study
Official title: A Prospective, Non-Interventional Study to Determine Signs and Symptoms That Impact Daily Life of Patients With Irregular Sleep-Wake Rhythm Disorder and Their Caregivers
The primary purpose of this study is to determine the signs and symptoms of irregular sleep-wake rhythm disorder (ISWRD) that are important to patients and caregivers of patients with Alzheimer's disease dementia (AD-D), AD-D with cerebrovascular disease (CVD), and/or vascular dementia (VaD) and ISWRD, and to draft an instrument or instruments to assess them.
Read the detailed description
The study is comprised of an interview with patients and caregivers to determine the signs and symptoms of ISWRD that are important to patients and caregivers of patients.
- Conditions
- Irregular Sleep Wake Rhythm Disorder
- Being tested
- Non-interventional
- Keywords
- Irregular Sleep-Wake Rhythm Disorder, Alzheimer's disease dementia, Vascular dementia, Circadian Rhythm Sleep Disorder
- Medical subject headings
- Dementia, Vascular, Sleep Disorders, Circadian Rhythm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventionalOther
No intervention will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Patients and Caregivers: Overall Population | Overall population of this study will include both patients with ISWRD associated with AD-D, AD-D with CVD, and/or VaD, and care givers of patients. Patients and caregivers will undergo all study procedures. Caregivers may care either for a patients who undergo all study procedure (including interview) as well for patients who do not undergo any study procedures but give consent or assent for the use of their medical records in the study ("non-interviewed patient"). Receives: Other: Non-interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of Scale for the Assessment of the Signs and Symptoms of Irregular Sleep-wake Rhythm Disorder (ISWRD) Based on Interview Data
Development of scale for the assessment of the signs and symptoms of ISWRD based on interview data of participants using ATLAS ti Coding software will be reported. This study will determine the sleep-wake symptoms and signs that are the most relevant and important from the patient and caregiver perspectives.
Measured: Up to approximately 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start9 Jul 2020
- Primary completion7 Sep 2020
- Study completion7 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irregular Sleep Wake Rhythm DisorderStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The 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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04300569
- Sponsor's protocol ID
- E2006-A001-111
- Status last verified
- Mar 2020
- First submitted
- 6 Mar 2020
- Last updated
- 27 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Eisai's data sharing commitment and further information on how to request data can be found on the Eisai website http://eisaiclinicaltrials.com/.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-Interventional Study to Determine Signs and Symptoms That Impact Daily Life of Patients With Irregular Sleep-Wake Rhythm Disorder and Their Caregivers
- ClinicalTrials.gov ID
- NCT04300569
- Acronym / sponsor ID
- E2006-A001-111
- Conditions
- Irregular Sleep Wake Rhythm Disorder
- Keywords
- Irregular Sleep-Wake Rhythm Disorder, Alzheimer's disease dementia, Vascular dementia, Circadian Rhythm Sleep Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Jul 2020 (actual)
- Primary completion
- 7 Sep 2020 (actual)
- Study completion
- 7 Sep 2020 (actual)
- First posted
- 9 Mar 2020 (actual)
- 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 primary purpose of this study is to determine the signs and symptoms of irregular sleep-wake rhythm disorder (ISWRD) that are important to patients and caregivers of patients with Alzheimer's disease dementia (AD-D), AD-D with cerebrovascular disease (CVD), and/or vascular dementia (VaD) and ISWRD, and to draft an instrument or instruments to assess them.
Detailed description
The study is comprised of an interview with patients and caregivers to determine the signs and symptoms of ISWRD that are important to patients and caregivers of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients and Caregivers: Overall Population | – | Other: Non-interventionalOverall population of this study will include both patients with ISWRD associated with AD-D, AD-D with CVD, and/or VaD, and care givers of patients. Patients and caregivers will undergo all study procedures. Caregivers may care either for a patients who undergo all study procedure (including interview) as well for patients who do not undergo any study procedures but give consent or assent for the use of their medical records in the study ("non-interviewed patient"). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with AD-D, AD-D with CVD and/or VaD and ISWRD and caregivers of patients.
Key inclusion criteria (20 listed)
- Patient Participants
- Age 60 to 90 years at time of informed consent
- Documentation of diagnosis of AD-D on the basis of the clinical criteria of the National Institute on Aging/Alzheimer's Association (NIA-AA) diagnostic guidelines and/or VaD on the basis of the National Institute of Neurological Disorders and Stroke (NINDS) and the Association Internationale pour la Recherche et l'Enseignement en Neurosciences (AIREN) criteria, and AD-D with CVD on the basis of NINDS-AIREN criteria
- If the Mini Mental State Examination (MMSE) is conducted (mandatory for clinic visits only) or is available within the past 3 months (all patient participants), MMSE 10 to 26. Note: For all patient participants who undergo a clinic visit, an MMSE must be conducted unless this has been assessed within the past 3 months and the score is available. No MMSE will be conducted during telephone visits, but if a recent MMSE is available, that is, within the past 3 months, that MMSE must be assessed for eligibility.
- Meets criteria for Circadian Rhythm Sleep Disorder, Irregular Sleep-Wake Type (Diagnostic and Statistical Manual of Mental Disorders - 5th edition [DSM-5]) and the 10th revision of the International Classification of Diseases (ICD-10), as follows: Complaint by the patient or caregiver that the patient has difficulty sleeping during the night and/or has excessive daytime sleepiness associated with multiple irregular sleep bouts during a 24-hour period
Key exclusion criteria (12 listed)
- Patient Participants
- A diagnosis of a Lewy body dementia (including Parkinson's disease dementia or dementia with Lewy bodies)
- A diagnosis of moderate or severe obstructive sleep apnea (OSA), or current use of continuous positive airway pressure (CPAP) even if mild OSA, restless legs syndrome or any other disorder except ISWRD that is likely to impact sleep and interfere with the assessment of ISWRD in the opinion of the investigator
- Caregivers
- The person for whom they care is a non-interviewed patient with any of the following:
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 |
|---|---|---|
| Non-interventionalNo intervention will be administered. | Other | Patients and Caregivers: Overall Population |
Primary outcome
Development of Scale for the Assessment of the Signs and Symptoms of Irregular Sleep-wake Rhythm Disorder (ISWRD) Based on Interview Data
Time frame: Up to approximately 3 weeks
Development of scale for the assessment of the signs and symptoms of ISWRD based on interview data of participants using ATLAS ti Coding software will be reported. This study will determine the sleep-wake symptoms and signs that are the most relevant and important from the patient and caregiver perspectives.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
- Individual participant dataSharing planned: Yes. Eisai's data sharing commitment and further information on how to request data can be found on the Eisai website http://eisaiclinicaltrials.com/.
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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Irregular Sleep Wake Rhythm Disorder, run by Eisai Inc. at 6 sites in United States.
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 20 inclusion and 12 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: finished, as of the sponsor's last update on 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Development of Scale for the Assessment of the Signs and Symptoms of Irregular Sleep-wake Rhythm Disorder (ISWRD) Based on Interview Data (time frame: Up to approximately 3 weeks). 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 27 Oct 2020.