Alzheimer's DiseaseNCT01920672
Disrupted Sleep, Neuroendocrine Status and the Behavioral Symptoms of AD
A study testing Timed Planned Activity and Home Safety and Education Program in people with Alzheimer's Disease, run by Johns Hopkins University at 1 site in United States.
Trial summary
Over 5 million Americans have Alzheimer's disease or a related dementia, a progressive and irreversible neurodegenerative condition, affecting also close to 15 million family caregivers (CG). Sleep efficiency in AD patients is severely impaired and complicated by frequent night awakenings and nocturnal restlessness. Read more about this study
- Who is it for?
- Ages 60 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Timed Planned Activity and Home Safety and Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Jun 2015
- Phase
- Interventional
- 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 60 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The inclusion/exclusion criteria are designed to obtain a sample of moderate stage AD patients because the sleep disruption we seek to assess occur most frequently at this stage. AD patients must: 1) have a diagnosis of probable AD (physician generated); 2) be over age 60; 3) be able to provide saliva samples; 4) be able to tolerate wrist actigraphy per caregiver report. Family caregivers must: 1) be English speaking; 2) have provided care for a minimum of 3 months; and 3) be the primary caregiver (self-identifies as providing the most day-to-day care).
Who cannot join
- To minimize the contribution of extraneous variables, subjects will be excluded for the following: regular use of medications with substantial known effects on the measurement of alpha amylase and cortisol (e.g. corticosteroids, interferons, beta-blockers, cytotoxic chemotherapy); major surgery in the past 3 months; history of major psychiatric and/or personality disorder; history of heavy cigarette smoking (e.g. >than 50 pack years); loss of a loved one in the past 3 months. Conditions known to affect measurement of sleep will also be excluded: use of sedatives/ hypnotics, Huntington's' disease, normal pressure hydrocephalus, Parkinson's disease, advanced heart failure (New York Heart Stage 3-4), morbid obesity (BMI > 35), and indications of restless legs syndrome or periodic limb movement disorder. We will exclude subjects screening positive for sleep apnea (actigraph/pulse oximetry oxygen desaturation index > 15).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Disrupted Sleep, Neuroendocrine Status and the Behavioral Symptoms of Alzheimer's Disease (AD)
Over 5 million Americans have Alzheimer's disease or a related dementia, a progressive and irreversible neurodegenerative condition, affecting also close to 15 million family caregivers (CG). Sleep efficiency in AD patients is severely impaired and complicated by frequent night awakenings and nocturnal restlessness. Untreated sleep disruption in AD patients is associated with increased rates of neuropsychiatric symptoms, daytime napping, 'sundowning' behaviors, cognitive and functional decline, and morbidity and mortality. The added strain of sleep disruption is the primary reason family caregivers make the decision to institutionalize AD patients. The circadian abnormalities in the sleep-wake cycle commonly observed in AD patients occur more often in individuals with hypothalamic/ pituitary/adrenal (HPA) axis hyperactivity. HPA axis hyperactivity may influence diurnal sleep-wake activity by diminishing an AD patient's ability to respond to external zeitgebers which, in turn, can further propagate HPA axis dysfunction. Thus, interventions to normalize diurnal HPA axis patterns may be beneficial in treating sleep-wake disturbances. Nonpharmacologic treatments are the first line therapy in AD patients with sleep wake problems, given the ineffective and potentially harmful effects of pharmacologic agents. Current clinical sleep hygiene practices in institutional (e.g., nursing home) settings holds promise for reducing disruptive sleep by reestablishing circadian patterns in HPA functioning. These interventions include use of timed and planned activities during daylight hours and creating a relaxing environment in the evening. However little systematic work has been done to determine the efficacy of these interventions in the home setting (where most individuals with AD reside).
We propose a pilot study to (a) characterize objective sleep parameters and behavioral symptoms of sleep-wake disturbance, and biological indicators of diurnal HPA axis activity in a sample of community residing older adults with AD: (b) examine the effects of timed and planned activities on subjective and objective characteristics of sleep, behavioral symptoms, and HPA status; and (c) evaluate measurement approaches in home-dwelling AD patients. Subjective (CG questionnaires) and objective (wrist actigraphy) characteristics of sleep and behavioral symptoms will be measured in fifty-four AD patients being cared for at home by a family. Patients and CG with then be randomized to receive an intervention of timed, planned activities (TPA) or attention control (AC) condition. We will also obtain diurnal measures of HPA activity including salivary cortisol and alpha amylase.
- Conditions
- Alzheimer's Disease
- Being tested
- Timed Planned Activity, Home Safety and Education Program
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timed Planned ActivityBehavioural
Home Safety and Education ProgramBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Timed Planned Activity (TPA) | Experimental | The TPA provides meaningful activities delivered at specific times in the daily diurnal cycle; it is theory-based, its components have been tested in pilot work; and it is portable and replicable (e..g, protocols are standardized). It involves involved 8 contacts (6 home visits and 2 phone calls) over 4 days. At baseline the CG completes the Pleasant Event Activity Survey. From the survey a careplan of meaningful activities are developed for the CG to administer. The suggested activities match the capabilities of an individual with moderate stage AD ie., based on repetitive motion (e.g., folding towels) and integrating multi-sensory stimulation (e.g., soft music, objects pleasant to touch). CG are instructed to introduce these activities during the late morning and early evening. Receives: Behavioral: Timed Planned Activity |
| Home Safety and Education Program | Active comparator | The active comparator intervention will be delivered by interventionists who will provide social attention, empathy and engagement similar to that afforded to the experimental group. The length of time spent will be comparable to the length of time spent in the treatment arm. The attention-control group will involve 6 in-home visits in the afternoon and 2 brief telephone education sessions in the morning. Control group subjects will be provided a copy of Mace and Rabins, The 36-Hour Day, a well-known practical guidebook for families caring for AD patients. Each contact will provide helpful education based on a specific book chapter including information about home safety, health promotion, and advanced care planning Receives: Behavioral: Home Safety and Education Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
total sleep time
total minutes of sleep
Measured: 10 days
Secondary outcomes (1)
Wake after sleep onset
number of episodes of wake activity after "lights out"
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Nancy A Hodgson, PhD, Principal investigator, Johns Hopkins Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01920672
- Sponsor's protocol ID
- NA_00088139
- Other IDs
- P30NR014131
- Status last verified
- Dec 2017
- First submitted
- 6 Aug 2013
- Last updated
- 12 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disrupted Sleep, Neuroendocrine Status and the Behavioral Symptoms of Alzheimer's Disease (AD)
- ClinicalTrials.gov ID
- NCT01920672
- Acronym / sponsor ID
- NA_00088139
- Conditions
- Alzheimer's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Sep 2013 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 12 Aug 2013 (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.
Over 5 million Americans have Alzheimer's disease or a related dementia, a progressive and irreversible neurodegenerative condition, affecting also close to 15 million family caregivers (CG). Sleep efficiency in AD patients is severely impaired and complicated by frequent night awakenings and nocturnal restlessness. Untreated sleep disruption in AD patients is associated with increased rates of neuropsychiatric symptoms, daytime napping, 'sundowning' behaviors, cognitive and functional decline, and morbidity and mortality. The added strain of sleep disruption is the primary reason family caregivers make the decision to institutionalize AD patients. The circadian abnormalities in the sleep-wake cycle commonly observed in AD patients occur more often in individuals with hypothalamic/ pituitary/adrenal (HPA) axis hyperactivity. HPA axis hyperactivity may influence diurnal sleep-wake activity by diminishing an AD patient's ability to respond to external zeitgebers which, in turn, can further propagate HPA axis dysfunction. Thus, interventions to normalize diurnal HPA axis patterns may be beneficial in treating sleep-wake disturbances. Nonpharmacologic treatments are the first line therapy in AD patients with sleep wake problems, given the ineffective and potentially harmful effects of pharmacologic agents. Current clinical sleep hygiene practices in institutional (e.g., nursing home) settings holds promise for reducing disruptive sleep by reestablishing circadian patterns in HPA functioning. These interventions include use of timed and planned activities during daylight hours and creating a relaxing environment in the evening. However little systematic work has been done to determine the efficacy of these interventions in the home setting (where most individuals with AD reside).
We propose a pilot study to (a) characterize objective sleep parameters and behavioral symptoms of sleep-wake disturbance, and biological indicators of diurnal HPA axis activity in a sample of community residing older adults with AD: (b) examine the effects of timed and planned activities on subjective and objective characteristics of sleep, behavioral symptoms, and HPA status; and (c) evaluate measurement approaches in home-dwelling AD patients. Subjective (CG questionnaires) and objective (wrist actigraphy) characteristics of sleep and behavioral symptoms will be measured in fifty-four AD patients being cared for at home by a family. Patients and CG with then be randomized to receive an intervention of timed, planned activities (TPA) or attention control (AC) condition. We will also obtain diurnal measures of HPA activity including salivary cortisol and alpha amylase.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Timed Planned Activity (TPA) | Experimental | Behavioral: Timed Planned ActivityThe TPA provides meaningful activities delivered at specific times in the daily diurnal cycle; it is theory-based, its components have been tested in pilot work; and it is portable and replicable (e..g, protocols are standardized). It involves involved 8 contacts (6 home visits and 2 phone calls) over 4 days. At baseline the CG completes the Pleasant Event Activity Survey. From the survey a careplan of meaningful activities are developed for the CG to administer. The suggested activities match the capabilities of an individual with moderate stage AD ie., based on repetitive motion (e.g., folding towels) and integrating multi-sensory stimulation (e.g., soft music, objects pleasant to touch). CG are instructed to introduce these activities during the late morning and early evening. |
| Home Safety and Education Program | Active comparator | Behavioral: Home Safety and Education ProgramThe active comparator intervention will be delivered by interventionists who will provide social attention, empathy and engagement similar to that afforded to the experimental group. The length of time spent will be comparable to the length of time spent in the treatment arm. The attention-control group will involve 6 in-home visits in the afternoon and 2 brief telephone education sessions in the morning. Control group subjects will be provided a copy of Mace and Rabins, The 36-Hour Day, a well-known practical guidebook for families caring for AD patients. Each contact will provide helpful education based on a specific book chapter including information about home safety, health promotion, and advanced care planning |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The inclusion/exclusion criteria are designed to obtain a sample of moderate stage AD patients because the sleep disruption we seek to assess occur most frequently at this stage. AD patients must: 1) have a diagnosis of probable AD (physician generated); 2) be over age 60; 3) be able to provide saliva samples; 4) be able to tolerate wrist actigraphy per caregiver report. Family caregivers must: 1) be English speaking; 2) have provided care for a minimum of 3 months; and 3) be the primary caregiver (self-identifies as providing the most day-to-day care).
Key exclusion criteria (1 listed)
- To minimize the contribution of extraneous variables, subjects will be excluded for the following: regular use of medications with substantial known effects on the measurement of alpha amylase and cortisol (e.g. corticosteroids, interferons, beta-blockers, cytotoxic chemotherapy); major surgery in the past 3 months; history of major psychiatric and/or personality disorder; history of heavy cigarette smoking (e.g. >than 50 pack years); loss of a loved one in the past 3 months. Conditions known to affect measurement of sleep will also be excluded: use of sedatives/ hypnotics, Huntington's' disease, normal pressure hydrocephalus, Parkinson's disease, advanced heart failure (New York Heart Stage 3-4), morbid obesity (BMI > 35), and indications of restless legs syndrome or periodic limb movement disorder. We will exclude subjects screening positive for sleep apnea (actigraph/pulse oximetry oxygen desaturation index > 15).
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 |
|---|---|---|
| Timed Planned Activity | Behavioural | Timed Planned Activity (TPA) |
| Home Safety and Education Program | Behavioural | Home Safety and Education Program |
Primary outcome
total sleep time
Time frame: 10 days
total minutes of sleep
1 secondary outcome
Wake after sleep onset
Time frame: 10 days
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 12 Dec 2017.
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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.
Nancy A Hodgson, PhD principal investigator
Johns Hopkins Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Timed Planned Activity and Home Safety and Education Program in people with Alzheimer's Disease, run by Johns Hopkins University at 1 site 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 1 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: finished, as of the sponsor's last update on 12 Dec 2017. 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 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?
total sleep time (time frame: 10 days). 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 12 Dec 2017.