Caregivers of Persons With DementiaNCT01550172
Improving Dementia Caregiver Sleep & the Effect on Heart Disease Biomarkers
A study testing Sleep Behavioral Therapy A and NHMS and Sleep Behavioral Therapy B and NHMS in people with Caregivers of Persons With Dementia, run by University of South Florida at 1 site in United States.
Trial summary
The purpose of the study is to determine whether a combined intervention of a night home monitoring system and cognitive-behavioral therapy for insomnia (CBTi) is effective in improving sleep in dementia caregivers who arise at night. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Caregivers of Persons With Dementia
- What is being tested?
- Sleep Behavioral Therapy A and NHMS and Sleep Behavioral Therapy B and NHMS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Jul 2016
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary caregiver for a relative who has been diagnosed by a physician with dementia or Alzheimer's disease.
- Persons with dementia sleep in the same location each night.
- Caregiver provides care for persons with dementia with nighttime activity that occurs at least one night/week.
- Caregiver meets the standard criteria for Insomnia.
- Caregiver sleep problems affect daytime functioning.
- If caregiver uses sleep medication, dose stable for 6 months.
- Caregiver Telephone Interview for Cognitive Status Score > 25.
- Caregiver does not require assistive devices to walk in the home at night.
Who cannot join
- Caregiver receives respite care at night the majority of the time.
- Caregiver has diagnosed sleep disorder.
- Caregiver uses CPAP at night
- Caregiver has chronic illness that requires frequent, weekly treatment/assessment by a healthcare provider.
- Current use of anticoagulant medication by the caregiver.
- Caregiver Sleep Apnea-Hypopnea Index (AHI) score > 10 or > 15 if pulse oximetry ≥ 88%.
- Caregiver shows evidence of Restless Leg Syndrome per the Cambridge-Hopkins Restless Leg Syndrome Questionnaire.
- Montreal Cognitive Assessment (MOCA) score < 26.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to determine whether a combined intervention of a night home monitoring system and cognitive-behavioral therapy for insomnia (CBTi) is effective in improving sleep in dementia caregivers who arise at night.
Read the detailed description
Informal caregivers provide the majority of care for chronically ill adults, including persons with dementia. While these individuals provide a great benefit to the chronically ill relative, being a caregiver is associated with deleterious health consequences, including premature mortality and higher rates of coronary heart disease (CHD). Another common complaint among dementia caregivers is poor sleep, which has been connected to premature mortality and higher rates of CHD in noncaregiving adults. Currently no sleep therapies are empirically validated as effective for caregivers of persons with dementia (PWD), and since PWD often arise at night, improving caregiver sleep could be potentially hazardous as a sleeping caregiver cannot provide supervision during night awakenings. Our primary purpose is thus to determine whether a combined intervention is effective in improving sleep in caregivers of PWD who arise at night. The intervention consists of a night home monitoring system that provides reliable alerts to caregivers when PWD leave the bed and move through the house. While this system improved home safety for PWD, it did not affect caregiver sleep, so a more traditional sleep therapy will be added-cognitive-behavioral therapy for insomnia. In the proposed study, experimental participants will receive the night home monitoring system + CBTi; active comparator participants will receive the night home monitoring system and sleep behavioral therapy. Participants will remain in the study for 29 weeks, with 4 data collection points. We hypothesize experimental participants will have less time awake after going to bed, and improved sleep efficiency (percent time asleep while in bed). Sleep data will be collected for multiple nights using actigraphy and sleep diary. Our secondary research questions focus on the relationship between poor sleep and CHD. Both in adults and in dementia caregivers, there appears to be a link between poor sleep and abnormal levels on coronary heart disease biomarkers, and likely an increase in CHD with poor sleep. We aim to further explore this relationship as well as determine whether levels of biomarkers improve with improved sleep from the intervention. We propose to draw blood samples at 4 data collection points and measure a set of biomarkers indicative of CHD.
- Conditions
- Caregivers of Persons With Dementia
- Being tested
- Sleep Behavioral Therapy A and NHMS, Sleep Behavioral Therapy B and NHMS
- Keywords
- dementia caregivers, caregivers, Alzheimer's caregivers, caregiver sleep, heart disease risk, dementia, Alzheimer's Disease
- Medical subject headings
- Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Behavioral Therapy A and NHMSBehavioural
The night home monitoring system provides caregivers with reliable alerts and information regarding the whereabouts of the person with dementia during the night.
Sleep behavioral therapy A uses a combination of cognitive exercises and behavior adjustments.
Sleep Behavioral Therapy B and NHMSBehavioural
The night home monitoring system (NHMS) provides caregivers with reliable alerts and information regarding the whereabouts of the person with dementia during the night.
Sleep behavioral therapy B uses primarily behavioral adjustments.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Behavioral Therapy A and NHMS | Experimental | Participants in this arm receive behavioral therapy A for insomnia and the night home monitoring system. Receives: Behavioral: Sleep Behavioral Therapy A and NHMS |
| Sleep Behavioral Therapy B and NHMS | Active comparator | Participants in this arm receive sleep behavioral therapy B and the night home monitoring system. Receives: Behavioral: Sleep Behavioral Therapy B and NHMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Wake Time (TWT)
Actigraphy, using the Actiwatch2, will be used to measure objective sleep; We will collect data for 14-day periods using a 30-second epoch length to accurately capture night-to-night variability.
Subjects will also complete a sleep diary for each day of actigraphic data collection, which will provide subjective sleep values of TWT. Data collected include bedtime, sleep start, number awakenings, minutes awake during night, wake time, out-of-bed time, minutes spent napping the previous day, and a sleep quality rating.
Measured: Week 27-28
Sleep Efficiency (SE)
Actigraphy, using the Actiwatch2, will be used to measure objective sleep; We will collect data for 14-day periods using a 30-second epoch length to accurately capture night-to-night variability.
Subjects will also complete a sleep diary for each day of actigraphic data collection, which will provide subjective sleep values of SE. Data collected include bedtime, sleep start, number awakenings, minutes awake during night, wake time, out-of-bed time, minutes spent napping the previous day, and a sleep quality rating.
Measured: Week 27-28
Nighttime Injuries
The Caregiver will be asked about any PWD injuries that occurred since the last data collection point. Injuries will be coded according to the American National Standards method of recording injuries. The following data are collected: nature of injury; part of the body affected; object, substance, exposure, or bodily motion that caused the injury; event that directly resulted in the injury; and time and place of the injury's occurrence. An injury will be considered nighttime if the caregiver reported being asleep at the time the injury occurred.
Measured: Week 27-28
Secondary outcomes (5)
D-Dimer Levels
D-Dimer is a marker of coagulation activation and has been associated with coronary events. It has also been inversely associated with wake after sleep onset as well as poor sleep quality and low sleep efficiency. D-dimer is a byproduct of fibrinolysis which remains after a blood clot has been degraded. It consists of two cross linked fragments of fibrinogen. Elevated levels of D-dimer are a marker of thrombosis, as it might occur along atherosclerotic plaques in coronary blood vessels. D-dimer will be measured by monoclonal sandwich ELISA, which measures in the 3.9 - 250 ng/ml range.
Measured: Week 27
Tissue Plasminogen Activator Levels
Tissue Plasminogen Activator is an endothelial lining protein that catalyzes the conversion of plasminogen into plasmin, which is responsible for the degradation of fibrin into soluble degradation products. Caregivers of PWD showed higher levels of TPA. A meta-analysis of cardiovascular disease risk and TPA indicated that levels greater than 13.5 ng/ml increased CVD risk by 50%.
Measured: Week 27
C-reactive Protein (CRP) Levels
C-reactive protein (CRP) is a non-specific marker of inflammation shown in many studies to be elevated in AD caregivers and to be associated with poor sleep. High sensitivity CRP levels are consistently and independently associated with increased risk of cardiovascular events. HS-CRP will be measured by an ELISA.
Measured: Week 27
Intercellular Adhesion Molecule-1 (ICAM-1)
Intercellular adhesion molecule-1 (ICAM-1) is found in leukocytes and endothelium and is involved in adhesion of leukocytes to and through the endothelium. ICAM-1 is stimulated by the proinflammatory cytokines. ICAM-1 may participate in atherogenesis by increasing monocyte transmigration into the arterial intima.
Measured: Week 27
IL-6, and TNFα Levels
It is becoming apparent that sleep and immunity are strongly related and that impairments in sleep increase these circulating cytokine levels. Further, caregivers of Alzheimer's patients show both impaired sleep and elevated IL-6 and TNF-α. Levels of IL-6, IL-1, and TNF-α are partially controlled by sleep, and also regulate sleep and many aspects of the immune response. IL-6 and TNF-α are central mediators in the inflammatory process by regulating acute phase and coagulation protein, and inflammation plays a central role in the development and instability of atherosclerotic plaques.
Measured: Week 27
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Caregivers of Persons With DementiaStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Meredith Rowe, University of South Florida
- Investigators
- Meredeth Rowe, RN, PhD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01550172
- Sponsor's protocol ID
- 6201111800
- Other IDs
- 1R01AG039495-01
- Status last verified
- Oct 2016
- First submitted
- 1 Mar 2012
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Roth AJ, Curtis AF, Rowe MA, McCrae CS. Using Telehealth to Deliver Cognitive Behavioral Treatment of Insomnia to a Caregiver of a Person With Alzheimer's Disease. J Cogn Psychother. 2022 Feb 1;36(1):3-23. doi: 10.1891/JCPSY-D-20-00055.
PubMed 35121676
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Dementia Caregiver Sleep & the Effect on Heart Disease Biomarkers
- ClinicalTrials.gov ID
- NCT01550172
- Acronym / sponsor ID
- 6201111800
- Conditions
- Caregivers of Persons With Dementia
- Keywords
- dementia caregivers, caregivers, Alzheimer's caregivers, caregiver sleep, heart disease risk, dementia, Alzheimer's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Apr 2012
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 9 Mar 2012 (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 purpose of the study is to determine whether a combined intervention of a night home monitoring system and cognitive-behavioral therapy for insomnia (CBTi) is effective in improving sleep in dementia caregivers who arise at night.
Detailed description
Informal caregivers provide the majority of care for chronically ill adults, including persons with dementia. While these individuals provide a great benefit to the chronically ill relative, being a caregiver is associated with deleterious health consequences, including premature mortality and higher rates of coronary heart disease (CHD). Another common complaint among dementia caregivers is poor sleep, which has been connected to premature mortality and higher rates of CHD in noncaregiving adults. Currently no sleep therapies are empirically validated as effective for caregivers of persons with dementia (PWD), and since PWD often arise at night, improving caregiver sleep could be potentially hazardous as a sleeping caregiver cannot provide supervision during night awakenings. Our primary purpose is thus to determine whether a combined intervention is effective in improving sleep in caregivers of PWD who arise at night. The intervention consists of a night home monitoring system that provides reliable alerts to caregivers when PWD leave the bed and move through the house. While this system improved home safety for PWD, it did not affect caregiver sleep, so a more traditional sleep therapy will be added-cognitive-behavioral therapy for insomnia. In the proposed study, experimental participants will receive the night home monitoring system + CBTi; active comparator participants will receive the night home monitoring system and sleep behavioral therapy. Participants will remain in the study for 29 weeks, with 4 data collection points. We hypothesize experimental participants will have less time awake after going to bed, and improved sleep efficiency (percent time asleep while in bed). Sleep data will be collected for multiple nights using actigraphy and sleep diary. Our secondary research questions focus on the relationship between poor sleep and CHD. Both in adults and in dementia caregivers, there appears to be a link between poor sleep and abnormal levels on coronary heart disease biomarkers, and likely an increase in CHD with poor sleep. We aim to further explore this relationship as well as determine whether levels of biomarkers improve with improved sleep from the intervention. We propose to draw blood samples at 4 data collection points and measure a set of biomarkers indicative of CHD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep Behavioral Therapy A and NHMS | Experimental | Behavioral: Sleep Behavioral Therapy A and NHMSParticipants in this arm receive behavioral therapy A for insomnia and the night home monitoring system. |
| Sleep Behavioral Therapy B and NHMS | Active comparator | Behavioral: Sleep Behavioral Therapy B and NHMSParticipants in this arm receive sleep behavioral therapy B and the night home monitoring system. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Primary caregiver for a relative who has been diagnosed by a physician with dementia or Alzheimer's disease.
- Persons with dementia sleep in the same location each night.
- Caregiver provides care for persons with dementia with nighttime activity that occurs at least one night/week.
- Caregiver meets the standard criteria for Insomnia.
- Caregiver sleep problems affect daytime functioning.
Key exclusion criteria (8 listed)
- Caregiver receives respite care at night the majority of the time.
- Caregiver has diagnosed sleep disorder.
- Caregiver uses CPAP at night
- Caregiver has chronic illness that requires frequent, weekly treatment/assessment by a healthcare provider.
- Current use of anticoagulant medication by the caregiver.
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 |
|---|---|---|
| Sleep Behavioral Therapy A and NHMSThe night home monitoring system provides caregivers with reliable alerts and information regarding the whereabouts of the person with dementia during the night. Sleep behavioral therapy A uses a combination of cognitive exercises and behavior adjustments. | Behavioural | Sleep Behavioral Therapy A and NHMS |
| Sleep Behavioral Therapy B and NHMSThe night home monitoring system (NHMS) provides caregivers with reliable alerts and information regarding the whereabouts of the person with dementia during the night. Sleep behavioral therapy B uses primarily behavioral adjustments. | Behavioural | Sleep Behavioral Therapy B and NHMS |
Primary outcome
Total Wake Time (TWT)
Time frame: Week 27-28
Actigraphy, using the Actiwatch2, will be used to measure objective sleep; We will collect data for 14-day periods using a 30-second epoch length to accurately capture night-to-night variability. Subjects will also complete a sleep diary for each day of actigraphic data collection, which will provide subjective sleep values of TWT. Data collected include bedtime, sleep start, number awakenings, minutes awake during night, wake time, out-of-bed time, minutes spent napping the previous day, and a sleep quality rating.
Sleep Efficiency (SE)
Time frame: Week 27-28
Actigraphy, using the Actiwatch2, will be used to measure objective sleep; We will collect data for 14-day periods using a 30-second epoch length to accurately capture night-to-night variability. Subjects will also complete a sleep diary for each day of actigraphic data collection, which will provide subjective sleep values of SE. Data collected include bedtime, sleep start, number awakenings, minutes awake during night, wake time, out-of-bed time, minutes spent napping the previous day, and a sleep quality rating.
Nighttime Injuries
Time frame: Week 27-28
The Caregiver will be asked about any PWD injuries that occurred since the last data collection point. Injuries will be coded according to the American National Standards method of recording injuries. The following data are collected: nature of injury; part of the body affected; object, substance, exposure, or bodily motion that caused the injury; event that directly resulted in the injury; and time and place of the injury's occurrence. An injury will be considered nighttime if the caregiver reported being asleep at the time the injury occurred.
5 secondary outcomes
D-Dimer Levels
Time frame: Week 27
Tissue Plasminogen Activator Levels
Time frame: Week 27
C-reactive Protein (CRP) Levels
Time frame: Week 27
Intercellular Adhesion Molecule-1 (ICAM-1)
Time frame: Week 27
IL-6, and TNFα Levels
Time frame: Week 27
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 26 Oct 2016.
- Derived from this study: PubMed 35121676Roth AJ, Curtis AF, Rowe MA, McCrae CS. Using Telehealth to Deliver Cognitive Behavioral Treatment of Insomnia to a Caregiver of a Person With Alzheimer's Disease. J Cogn Psychother. 2022 Feb 1;36(1):3-23. doi: 10.1891/JCPSY-D-20-00055.
Related trials for Caregivers of Persons With Dementia
Active, not recruiting
Health enSuite Caregivers: an App-based Treatment for Distressed Caregivers of Persons With Moderate Dementia
Caregiver Burnout
Recruiting
VOCALE LBD: Online Peer Support for Caregivers of People With Lewy Body Dementia
Lewy Bodies Disease, Depression Disorder
RecruitingPhase 2
Intranasal Oxytocin Intervention for Caregivers to Persons With Dementia
Stress
Recruiting
Buddy-Up Dyadic Physical Activity Program for Persons With Dementia and Family Caregivers
Cognitive Impairment, Mild, Dementia, Mild
Recruiting
Integrative Therapeutic Programme to Regulate Expressed Emotions Among Informal Caregivers of People With Dementia
BPSD (Behavioral and Psycological Symptoms of Dementia), Expressed Emotion
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.
Meredeth Rowe, RN, PhD principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Behavioral Therapy A and NHMS and Sleep Behavioral Therapy B and NHMS in people with Caregivers of Persons With Dementia, run by University of South Florida 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 8 inclusion and 8 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 26 Oct 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 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 Wake Time (TWT) (time frame: Week 27-28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01550172, which also lists 1 linked publication.
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 26 Oct 2016.