Cardiac ArrhythmiaPhase 2SAVENCT02232204
Sleep and Ventricular Arrhythmias Study
A Phase 2 study testing CBT for Insomnia in ICD Patients (CBT-I-ICD) in people with Cardiac Arrhythmia and Implantable Defibrillator User, run by University of Florida at 1 site in United States.
Trial summary
This is a single-center, randomized controlled trial study design. Enrolled participants have a cardiovascular condition for which they are undergoing implantable cardioverter defibrillator (ICD) therapy and comorbid insomnia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrhythmia, Implantable Defibrillator User, Insomnia
- What is being tested?
- CBT for Insomnia in ICD Patients (CBT-I-ICD)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Jan 2012
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current ICD implantation (single or dual lead ICD, ICD and pacemaker)
- Diagnosis of insomnia
- No sleep medications for at least 1 month, or stable on medications for at least 6 months
- Willing to be randomly assigned to treatment
- Able to read and understand English
Who cannot join
- Sleep disorder other than insomnia
- Significant medical condition other than cardiac disease
- Severe untreated psychopathology
- Neurological disorder
- Cognitive impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida Aging
Gainesville, Florida, 32610
About this study
Official title: Sleep in Cardiac Patients With Implantable Cardioverter Defibrillators (ICD)
This is a single-center, randomized controlled trial study design. Enrolled participants have a cardiovascular condition for which they are undergoing implantable cardioverter defibrillator (ICD) therapy and comorbid insomnia. Participants were randomized to a behavioral intervention for insomnia in ICD patients or a waitlist control. The treatment intervention period lasted 4 weeks with a telephone booster session administered at 3 month follow-up. The objective of the study is to examine the impact of a brief therapy combining established behavioral approaches to treating insomnia with novel components to target negative cognitions and anxieties associated with cardiac disease and ICD implantation. Primary patient outcomes include sleep, psychological functioning, daytime functioning, cardiac functioning, cognitive performance, and ICD adjustment.
Read the detailed description
Participants will be asked to review the informed consent form and consent to the study prior to beginning any study procedure.
There are six phases of this study: (1) an in-person interview, (2) an in-home single night sleep recording, (3) a two-week baseline period, (4) a 4-week treatment period, (5) a follow-up period immediately after the completion of treatment, (6) and a two-week follow-up period 3-months after the treatment period.
During the interview, participants will be asked questions about their sleep, cardiac, and ICD history. Participants will then visit the University of Florida for a medical history and will be connected to machinery to monitor their sleep. Participants will return home to sleep while still connected to the machine and will return the machine to the University of Florida the next day. A third visit will consist of completing questionnaires and a computerized neurocognitive performance battery to assess several areas of cognitive functioning. Participants will then go home and with brief daily diaries to complete for two weeks while also wearing an actigraph (wristwatch-like device) that measures arm movements to detect sleep/wake during that time.
Participants will then be randomized to (a) the brief cognitive behavioral therapy for insomnia (CBTi) in ICD patients group or (b) the waitlist control group. The treatment consists of 2 weeks of in-person therapy and 2 weeks of therapy conducted over the telephone. Participants assigned to waitlist control will be offered therapy at no cost at the end of the study. Throughout the 4 treatment weeks, participants in both groups will be asked to complete daily sleep diaries.
A follow-up period consisting of two weeks, during which participants will wear the actigraph and complete daily sleep diaries, will take place immediately after treatment completion. Participants will travel to the University two times during this follow-up period in order to pick-up and then return the actigraph and sleep diaries, and will once again complete the questionnaires and neurocognitive testing battery at the end of the 2nd visit. A final follow-up period will occur 3-months following treatment, which will involve visits to the University to pick up the daily sleep diaries and actigraph for sleep monitoring, and then returning these items after completion 2-weeks later. Upon returning the diary and actigraph, participants will complete questionnaires and then be debriefed by study personnel.
- Conditions
- Cardiac Arrhythmia, Implantable Defibrillator User, Insomnia
- Being tested
- CBT for Insomnia in ICD Patients (CBT-I-ICD)
- Keywords
- insomnia, implantable cardioverter defibrillator, cardiac arrhythmia, cognitive behavioral treatment
- Medical subject headings
- Arrhythmias, Cardiac, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT for Insomnia in ICD Patients (CBT-I-ICD)Behavioural
Participants will complete 4 weekly therapy sessions focused on improving sleep and reducing ICD-related stress. A multicomponent CBT-I-ICD (Cognitive Behavioral Therapy for Insomnia in ICD Patients) protocol will involve: sleep hygiene, stimulus control, sleep restriction, relaxation, cognitive restructuring, ICD education and recall information, shock planning, and quality of life-improvement recommendations.
| Study group | Role | What they receive |
|---|---|---|
| CBT for Insomnia in ICD Patients (CBT-I-ICD) | Active comparator | Participants will complete 4 weekly therapy sessions focused on improving sleep and reducing ICD-related stress. A multicomponent CBT-I-ICD (Cognitive Behavioral Therapy for Insomnia in ICD Patients) protocol will involve: sleep hygiene, stimulus control, sleep restriction, relaxation, cognitive restructuring, ICD education and recall information, shock planning, and quality of life-improvement recommendations. Receives: Behavioral: CBT for Insomnia in ICD Patients (CBT-I-ICD) |
| Waitlist Control (WLC) | No intervention | Participants in the WLC group will not receive any treatment between the baseline and post-treatment assessments. After the final follow-up assessment, they will be offered the opportunity to receive CBT-I-ICD. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in subjective and objective sleep
Sleep diary and actigraphy-derived sleep parameters (averaged over each 14-day data collection period at baseline, post-treatment, and at 3-month follow-up) including: time to fall asleep (sleep onset latency), wake time during the night (waketime after sleep onset), total sleep time, amount of time spent in bed sleeping (sleep efficiency), total nap time, and sleep quality rating.
Measured: Change from baseline to the two study follow-ups (immediately and 3-months following treatment)
Secondary outcomes (6)
Change in psychological functioning
Changes in reported symptoms of anxiety and depression as assessed by questionnaires from baseline to immediately and 3 months following treatment.
Measured: Change from baseline to the two follow-up periods (immediately and 3-months following treatment)
Change in daytime functioning
The change in reported insomnia impact, fatigue, and sleepiness as assessed by questionnaires from baseline to immediately and 3 months following treatment.
Measured: Change from baseline to the two follow-up periods (immediately and 3-months following treatment)
Change in quality of life
The change in reported health-related quality of life as assessed by questionnaires from baseline to immediately and 3 months following treatment.
Measured: Change from baseline to the two follow-up periods (immediately and 3-months following treatment)
Change in cardiac functioning
The change in device-recorded incidence of ventricular arrhythmia from baseline to immediately and 3 months following treatment.
Measured: Change from baseline to the two follow-up periods (immediately and 3-months following treatment)
Change in device adjustment
The change in reported shock anxiety and device-specific acceptance as assessed by questionnaires from baseline to immediately and 3 months following treatment.
Measured: Change from baseline to the two follow-up periods (immediately and 3-months following treatment
Change in cognitive functioning
The change in computer-recorded cognitive functioning in the domains of executive control, reasoning, working memory, attention, and reaction time as assessed from baseline to immediately following treatment.
Measured: Change from baseline to immediately after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2014 (estimated)
- Study startOct 2009
- Primary completionOct 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrhythmiaStudies of the same condition, open and under way.
- More trials run by University of 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Christina S McCrae, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02232204
- Sponsor's protocol ID
- 157-2008
- Other IDs
- R21HL087831
- Acronym
- SAVE
- Status last verified
- Sep 2014
- First submitted
- 2 Sep 2014
- Last updated
- 5 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep in Cardiac Patients With Implantable Cardioverter Defibrillators (ICD)
- ClinicalTrials.gov ID
- NCT02232204
- Acronym / sponsor ID
- SAVE / 157-2008
- Conditions
- Cardiac Arrhythmia, Implantable Defibrillator User, Insomnia
- Keywords
- insomnia, implantable cardioverter defibrillator, cardiac arrhythmia, cognitive behavioral treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Oct 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 5 Sep 2014 (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.
This is a single-center, randomized controlled trial study design. Enrolled participants have a cardiovascular condition for which they are undergoing implantable cardioverter defibrillator (ICD) therapy and comorbid insomnia. Participants were randomized to a behavioral intervention for insomnia in ICD patients or a waitlist control. The treatment intervention period lasted 4 weeks with a telephone booster session administered at 3 month follow-up. The objective of the study is to examine the impact of a brief therapy combining established behavioral approaches to treating insomnia with novel components to target negative cognitions and anxieties associated with cardiac disease and ICD implantation. Primary patient outcomes include sleep, psychological functioning, daytime functioning, cardiac functioning, cognitive performance, and ICD adjustment.
Detailed description
Participants will be asked to review the informed consent form and consent to the study prior to beginning any study procedure.
There are six phases of this study: (1) an in-person interview, (2) an in-home single night sleep recording, (3) a two-week baseline period, (4) a 4-week treatment period, (5) a follow-up period immediately after the completion of treatment, (6) and a two-week follow-up period 3-months after the treatment period.
During the interview, participants will be asked questions about their sleep, cardiac, and ICD history. Participants will then visit the University of Florida for a medical history and will be connected to machinery to monitor their sleep. Participants will return home to sleep while still connected to the machine and will return the machine to the University of Florida the next day. A third visit will consist of completing questionnaires and a computerized neurocognitive performance battery to assess several areas of cognitive functioning. Participants will then go home and with brief daily diaries to complete for two weeks while also wearing an actigraph (wristwatch-like device) that measures arm movements to detect sleep/wake during that time.
Participants will then be randomized to (a) the brief cognitive behavioral therapy for insomnia (CBTi) in ICD patients group or (b) the waitlist control group. The treatment consists of 2 weeks of in-person therapy and 2 weeks of therapy conducted over the telephone. Participants assigned to waitlist control will be offered therapy at no cost at the end of the study. Throughout the 4 treatment weeks, participants in both groups will be asked to complete daily sleep diaries.
A follow-up period consisting of two weeks, during which participants will wear the actigraph and complete daily sleep diaries, will take place immediately after treatment completion. Participants will travel to the University two times during this follow-up period in order to pick-up and then return the actigraph and sleep diaries, and will once again complete the questionnaires and neurocognitive testing battery at the end of the 2nd visit. A final follow-up period will occur 3-months following treatment, which will involve visits to the University to pick up the daily sleep diaries and actigraph for sleep monitoring, and then returning these items after completion 2-weeks later. Upon returning the diary and actigraph, participants will complete questionnaires and then be debriefed by study personnel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT for Insomnia in ICD Patients (CBT-I-ICD) | Active comparator | Behavioral: CBT for Insomnia in ICD Patients (CBT-I-ICD)Participants will complete 4 weekly therapy sessions focused on improving sleep and reducing ICD-related stress. A multicomponent CBT-I-ICD (Cognitive Behavioral Therapy for Insomnia in ICD Patients) protocol will involve: sleep hygiene, stimulus control, sleep restriction, relaxation, cognitive restructuring, ICD education and recall information, shock planning, and quality of life-improvement recommendations. |
| Waitlist Control (WLC) | No intervention | –Participants in the WLC group will not receive any treatment between the baseline and post-treatment assessments. After the final follow-up assessment, they will be offered the opportunity to receive CBT-I-ICD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Current ICD implantation (single or dual lead ICD, ICD and pacemaker)
- Diagnosis of insomnia
- No sleep medications for at least 1 month, or stable on medications for at least 6 months
- Willing to be randomly assigned to treatment
- Able to read and understand English
Key exclusion criteria (5 listed)
- Sleep disorder other than insomnia
- Significant medical condition other than cardiac disease
- Severe untreated psychopathology
- Neurological disorder
- Cognitive impairment
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 |
|---|---|---|
| CBT for Insomnia in ICD Patients (CBT-I-ICD)Participants will complete 4 weekly therapy sessions focused on improving sleep and reducing ICD-related stress. A multicomponent CBT-I-ICD (Cognitive Behavioral Therapy for Insomnia in ICD Patients) protocol will involve: sleep hygiene, stimulus control, sleep restriction, relaxation, cognitive restructuring, ICD education and recall information, shock planning, and quality of life-improvement recommendations. | Behavioural | CBT for Insomnia in ICD Patients (CBT-I-ICD) |
Primary outcome
Change in subjective and objective sleep
Time frame: Change from baseline to the two study follow-ups (immediately and 3-months following treatment)
Sleep diary and actigraphy-derived sleep parameters (averaged over each 14-day data collection period at baseline, post-treatment, and at 3-month follow-up) including: time to fall asleep (sleep onset latency), wake time during the night (waketime after sleep onset), total sleep time, amount of time spent in bed sleeping (sleep efficiency), total nap time, and sleep quality rating.
6 secondary outcomes
Change in psychological functioning
Time frame: Change from baseline to the two follow-up periods (immediately and 3-months following treatment)
Change in daytime functioning
Time frame: Change from baseline to the two follow-up periods (immediately and 3-months following treatment)
Change in quality of life
Time frame: Change from baseline to the two follow-up periods (immediately and 3-months following treatment)
Change in cardiac functioning
Time frame: Change from baseline to the two follow-up periods (immediately and 3-months following treatment)
Change in device adjustment
Time frame: Change from baseline to the two follow-up periods (immediately and 3-months following treatment
Change in cognitive functioning
Time frame: Change from baseline to immediately after treatment
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 5 Sep 2014.
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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.
Christina S McCrae, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CBT for Insomnia in ICD Patients (CBT-I-ICD) in people with Cardiac Arrhythmia and Implantable Defibrillator User, run by University of 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 5 inclusion and 5 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 5 Sep 2014. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in subjective and objective sleep (time frame: Change from baseline to the two study follow-ups (immediately and 3-months following treatment)). 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 5 Sep 2014.