InsomniaNCT02513017
Insomnia and Cardiovascular Diseases: Influence of Behavioral Treatments and Preferences
A study of Insomnia and Cardiovascular Disease, run by Toronto Metropolitan University.
Trial summary
Research has shown that persons who have trouble sleeping and experience stress are at risk of developing heart diseases. Two treatments, called stimulus control instructions and sleep efficiency treatment, that do not involve sleeping pills, have been found effective in managing trouble sleeping. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Insomnia, Cardiovascular Disease
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- No sites listed yet
- Study dates
- Feb 2009to Mar 2013
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Persons with insomnia will be eligible for the study if they:
- are community-dwelling, non-institutionalized middle-aged or older adults (> 40 years of age),
- have the ability to read and write English (required for providing written consent), and
- complain of difficulty initiating and/or maintaining sleep, manifested in sleep onset latency and/or time awake after sleep onset of 30 minutes or more per night, for a minimum of 3 nights per week, for a duration of at least 6 weeks (NIH, 2005), ascertained with relevant questions of the Insomnia Interview Schedule (Morin, 1993).
- Persons with insomnia will be selected if their insomnia is primary (i.e., not related to any other condition), or comorbid associated with pre-existing cardiovascular disease, anxiety, and depression only.
Who cannot join
- cognitive impairment as ascertained by the Mini-Mental State Exam (MMSE) score < 24 (Crum et al., 1993); cognitive impairment interferes with participants' understanding of, and ability to implement the behavioral interventions; and
- confirmed medical diagnosis and current treatment for sleep apnea as reported by participants; SCI and SRT are not recommended for sleep apnea.
About this study
Research has shown that persons who have trouble sleeping and experience stress are at risk of developing heart diseases. Two treatments, called stimulus control instructions and sleep efficiency treatment, that do not involve sleeping pills, have been found effective in managing trouble sleeping. This study will be undertaken to find out if the two treatments are effective in improving sleep, and reducing stress and the risk of heart diseases. Persons with trouble sleeping may have a preference for either treatment. It is believed that if persons get the treatment they prefer, then they will be satisfied with the treatment and comply with it, and experience improvement in their sleep. This study will also examine the extent to which giving persons the treatment of their choice, as compared to giving persons treatment based on chance, will lead to higher satisfaction and compliance with treatment, and improved sleep. About 300 persons who experience trouble sleeping will be included in the study. They will be requested to complete a questionnaire and a sleep diary before and after they receive treatment, as well as 6 month and one year later.
Read the detailed description
Background and Significance: Accumulating evidence indicates that sleep quantity (low number of sleep hours) and quality (subjective complaint of insomnia) are associated with an increased risk of cardiovascular diseases even after controlling for other cardiovascular risk factors. The prevalence of insomnia increases with age. Assisting middle-aged and older adults manage insomnia is essential to promote sleep, reduce anxiety and depression, and reduce the risk of cardiovascular diseases. Two behavioral treatments, stimulus control instructions (SCI) and sleep restriction therapy (SRT) are established treatments for insomnia. However, both treatments demand commitment to changing one's habits and lifestyle. Preferences for treatment have been found to influence adherence to, and outcomes of treatment. The study will provide experimental evidence of the extent to which improved sleep quantity and quality reduce the risk of cardiovascular diseases, and the SCI and SRT are effective in achieving these outcomes. The study is the first to examine satisfaction with treatment as the mechanism mediating the influence of preferences on treatment adherence and outcomes.
Objectives: The study addresses substantive and methodological areas of interest to the funding opportunity. The substantive objectives are: 1) to examine the direct effects of SCI and SRT on sleep (quantity and quality), psychological (anxiety, depression), and physical (cardiovascular symptoms and events) outcomes, and 2) to examine the indirect effects of SCI and SRT on psychological and physical outcomes, mediated through sleep quantity and quality. The methodological objectives are: 1) to compare participants randomized to treatment and participants allocated to treatment of choice on attrition, satisfaction with treatment, adherence to treatment, and sleep, psychological and physical outcomes; 2) among randomized participants, to compare those who receive and those who do not receive the preferred treatment on attrition, satisfaction with, and adherence to treatment, and sleep, psychological, and physical outcomes; and, 3) to explore the extent to which satisfaction with treatment mediates the influence of preferences on treatment adherence and outcomes.
Design: A two-stage partially randomized clinical trial will be used. Eligible participants will be randomized to the random and preference arms of the trial. In the random arm, participants will be randomly assigned to no-treatment, SCI or SRT. In the preference arm, participants will be allocated to SCI or SRT based on their preferences. Outcome data will be collected at 4 time points: pretest, posttest, and 6-month and 12-month follow-up.
Sample: Non-institutionalized, cognitively intact, adults (> 40 years) will be included if they complain of difficulty initiating and/or maintaining sleep (> 30 minutes per night, for > 3 nights per week, for > 6 weeks) that is not associated with sleep apnea. A sample of 60 participants per group, for a total of 300, is required to detect medium effects of the behavioral treatments and treatment preferences on sleep outcomes.
Measures: All outcomes will be measured with established measures. Adherence to treatment will be estimated with relevant data from the daily sleep diary. Preferences for, and satisfaction with treatment will be assessed with self-report instruments developed by the investigators and found reliable.
Analysis: In addition to descriptive statistics, hierarchical linear models and latent growth curve modeling will be used to address the objectives. The analysis will be repeated for participants who did and did not report cardiovascular diseases at baseline.
- Conditions
- Insomnia, Cardiovascular Disease
- Being tested
- Stimulus Control Instructions and Sleep Restriction Therapy
- Keywords
- partially randomized clinical trial, cardiovascular disease, insomnia, preference, acceptability
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stimulus Control Instructions and Sleep Restriction TherapyBehavioural
Please refer to arm/group descriptions.
| Study group | Role | What they receive |
|---|---|---|
| Stimulus Control Instructions (SCI) | Experimental | SCI is a behavioral treatment that aims to assist persons with insomnia to re-associate the bed and the bedroom with falling asleep or back to sleep, and to acquire a consistent sleep pattern. SCI entails specific instructions that focus on developing new sleep habits, such as avoiding activities other than sleep (e.g., reading, watching TV) in bed, and getting out of bed if unable to fall asleep and engaging in quiet activities until sleepy.
A trained therapist will deliver the session in which the following topics will be covered: education about sleep, factors that influence sleep, behaviors that promote or interfere with sleep, and SCI. The session will be offered in a small group (4-6) format, based on availability of participants and to avoid any delay in treatment receipt. Receives: Behavioral: Stimulus Control Instructions and Sleep Restriction Therapy |
| Sleep Restriction Therapy (SRT) | Experimental | SRT aims at consolidating sleep by limiting sleep to a specified time and restricting the amount of time spent in bed. Sleep time is individualized based on the persons' sleep needs, and the sleep-wake schedule is planned to fit the persons' lifestyle. The sleep-wake schedule is changed to accommodate improvements in the persons' sleep, over time.. A trained therapist will deliver the session in which the following topics will be covered: education about sleep, factors that influence sleep, behaviors that promote or interfere with sleep, and SRT. The session will be offered in a small group (4-6) format, based on availability of participants and to avoid any delay in treatment receipt. Receives: Behavioral: Stimulus Control Instructions and Sleep Restriction Therapy |
| No therapy | No intervention | No behavioral therapy for the management of insomnia is provided. However, a list of general recommendations and suggestions are provided to participants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Outcome Sleep Quantity Change over time
Sleep Outcomes include: sleep duration, sleep onset latency, wake after sleep onset, sleep efficiency, and daytime fatigue. The daily sleep diary (DSD) will be completed by participants to assess sleep quantity. The DSD is a self-administered log of nightly sleep behaviors. The DSD was developed by Morin (1993).
Measured: Sleep Quantity data will be collected at 4 time points: approximately at 2 weeks (pretest), posttest (at 5 weeks), 6-month and 12-month (1 year)
Sleep Outcome: Sleep Quality change over time
Insomnia Severity Index (ISI)
Measured: Sleep Quality data will be collected at 4 time points: at 2 weeks (pretest), posttest (at 5 weeks), 6-month and 12-month (1 year)
Secondary outcomes (3)
Psychological Outcomes: Anxiety change over time
Anxiety will be assessed with the 20-item State Trait Anxiety Inventory (STAI).
Measured: Psychological Outcome data will be collected at 4 time points: at 2 weeks (pretest), posttest (at 5 weeks), 6-month and 12-month (1 year)
Psychological Outcomes: Depression change over time
Center for Epidemiology Studies - Depression (CESD) scale
Measured: Psychological Outcome data will be collected at 4 time points: at 2 weeks (pretest), posttest (at 5 weeks), 6-month and 12-month (1 year)
Physical Outcomes: Cardiovascular Symptoms and Events Change over time
Physical outcomes include: cardiovascular symptoms and self-reported occurrence of cardiovascular events. The cardiovascular symptoms of chest pain, dyspnea, presyncope, and palpitation will be measured with relevant items derived from the Symptom Checklist (SCL) - 90R.
Measured: Physical Outcome data will be collected at 4 time points: at 2 weeks (pretest), posttest (at 5 weeks), and 6-month and 12-month follow-up (1 year).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2015 (estimated)
- Study startFeb 2009
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toronto Metropolitan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Souraya Sidani, Toronto Metropolitan University
- Investigators
- Dr. Souraya Sidani, PhD, Principal investigator, Toronto Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02513017
- Sponsor's protocol ID
- PCR - 101411
- Status last verified
- Jul 2015
- First submitted
- 22 Jul 2015
- Last updated
- 31 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Ibrahim S, Sidani S. Preferences for behavioral therapies for chronic insomnia. Health 5(11): 1784-1790, 2013.
Sidani S, Fox M, Streiner DL, Miranda J, Fredericks S, Epstein DR. Examining the influence of treatment preferences on attrition, adherence and outcomes: a protocol for a two-stage partially randomized trial. BMC Nurs. 2015 Nov 9;14:57. doi: 10.1186/s12912-015-0108-4. eCollection 2015.
PubMed 26557787
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insomnia and Cardiovascular Diseases: Influence of Behavioral Treatments and Preferences
- ClinicalTrials.gov ID
- NCT02513017
- Acronym / sponsor ID
- PCR - 101411
- Conditions
- Insomnia, Cardiovascular Disease
- Keywords
- partially randomized clinical trial, cardiovascular disease, insomnia, preference, acceptability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Toronto Metropolitan UniversityUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 31 Jul 2015 (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.
Research has shown that persons who have trouble sleeping and experience stress are at risk of developing heart diseases. Two treatments, called stimulus control instructions and sleep efficiency treatment, that do not involve sleeping pills, have been found effective in managing trouble sleeping. This study will be undertaken to find out if the two treatments are effective in improving sleep, and reducing stress and the risk of heart diseases. Persons with trouble sleeping may have a preference for either treatment. It is believed that if persons get the treatment they prefer, then they will be satisfied with the treatment and comply with it, and experience improvement in their sleep. This study will also examine the extent to which giving persons the treatment of their choice, as compared to giving persons treatment based on chance, will lead to higher satisfaction and compliance with treatment, and improved sleep. About 300 persons who experience trouble sleeping will be included in the study. They will be requested to complete a questionnaire and a sleep diary before and after they receive treatment, as well as 6 month and one year later.
Detailed description
Background and Significance: Accumulating evidence indicates that sleep quantity (low number of sleep hours) and quality (subjective complaint of insomnia) are associated with an increased risk of cardiovascular diseases even after controlling for other cardiovascular risk factors. The prevalence of insomnia increases with age. Assisting middle-aged and older adults manage insomnia is essential to promote sleep, reduce anxiety and depression, and reduce the risk of cardiovascular diseases. Two behavioral treatments, stimulus control instructions (SCI) and sleep restriction therapy (SRT) are established treatments for insomnia. However, both treatments demand commitment to changing one's habits and lifestyle. Preferences for treatment have been found to influence adherence to, and outcomes of treatment. The study will provide experimental evidence of the extent to which improved sleep quantity and quality reduce the risk of cardiovascular diseases, and the SCI and SRT are effective in achieving these outcomes. The study is the first to examine satisfaction with treatment as the mechanism mediating the influence of preferences on treatment adherence and outcomes.
Objectives: The study addresses substantive and methodological areas of interest to the funding opportunity. The substantive objectives are: 1) to examine the direct effects of SCI and SRT on sleep (quantity and quality), psychological (anxiety, depression), and physical (cardiovascular symptoms and events) outcomes, and 2) to examine the indirect effects of SCI and SRT on psychological and physical outcomes, mediated through sleep quantity and quality. The methodological objectives are: 1) to compare participants randomized to treatment and participants allocated to treatment of choice on attrition, satisfaction with treatment, adherence to treatment, and sleep, psychological and physical outcomes; 2) among randomized participants, to compare those who receive and those who do not receive the preferred treatment on attrition, satisfaction with, and adherence to treatment, and sleep, psychological, and physical outcomes; and, 3) to explore the extent to which satisfaction with treatment mediates the influence of preferences on treatment adherence and outcomes.
Design: A two-stage partially randomized clinical trial will be used. Eligible participants will be randomized to the random and preference arms of the trial. In the random arm, participants will be randomly assigned to no-treatment, SCI or SRT. In the preference arm, participants will be allocated to SCI or SRT based on their preferences. Outcome data will be collected at 4 time points: pretest, posttest, and 6-month and 12-month follow-up.
Sample: Non-institutionalized, cognitively intact, adults (> 40 years) will be included if they complain of difficulty initiating and/or maintaining sleep (> 30 minutes per night, for > 3 nights per week, for > 6 weeks) that is not associated with sleep apnea. A sample of 60 participants per group, for a total of 300, is required to detect medium effects of the behavioral treatments and treatment preferences on sleep outcomes.
Measures: All outcomes will be measured with established measures. Adherence to treatment will be estimated with relevant data from the daily sleep diary. Preferences for, and satisfaction with treatment will be assessed with self-report instruments developed by the investigators and found reliable.
Analysis: In addition to descriptive statistics, hierarchical linear models and latent growth curve modeling will be used to address the objectives. The analysis will be repeated for participants who did and did not report cardiovascular diseases at baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stimulus Control Instructions (SCI) | Experimental | Behavioral: Stimulus Control Instructions and Sleep Restriction TherapySCI is a behavioral treatment that aims to assist persons with insomnia to re-associate the bed and the bedroom with falling asleep or back to sleep, and to acquire a consistent sleep pattern. SCI entails specific instructions that focus on developing new sleep habits, such as avoiding activities other than sleep (e.g., reading, watching TV) in bed, and getting out of bed if unable to fall asleep and engaging in quiet activities until sleepy. A trained therapist will deliver the session in which the following topics will be covered: education about sleep, factors that influence sleep, behaviors that promote or interfere with sleep, and SCI. The session will be offered in a small group (4-6) format, based on availability of participants and to avoid any delay in treatment receipt. |
| Sleep Restriction Therapy (SRT) | Experimental | Behavioral: Stimulus Control Instructions and Sleep Restriction TherapySRT aims at consolidating sleep by limiting sleep to a specified time and restricting the amount of time spent in bed. Sleep time is individualized based on the persons' sleep needs, and the sleep-wake schedule is planned to fit the persons' lifestyle. The sleep-wake schedule is changed to accommodate improvements in the persons' sleep, over time.. A trained therapist will deliver the session in which the following topics will be covered: education about sleep, factors that influence sleep, behaviors that promote or interfere with sleep, and SRT. The session will be offered in a small group (4-6) format, based on availability of participants and to avoid any delay in treatment receipt. |
| No therapy | No intervention | –No behavioral therapy for the management of insomnia is provided. However, a list of general recommendations and suggestions are provided to participants. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- are community-dwelling, non-institutionalized middle-aged or older adults (> 40 years of age),
- have the ability to read and write English (required for providing written consent), and
- complain of difficulty initiating and/or maintaining sleep, manifested in sleep onset latency and/or time awake after sleep onset of 30 minutes or more per night, for a minimum of 3 nights per week, for a duration of at least 6 weeks (NIH, 2005), ascertained with relevant questions of the Insomnia Interview Schedule (Morin, 1993).
- Persons with insomnia will be selected if their insomnia is primary (i.e., not related to any other condition), or comorbid associated with pre-existing cardiovascular disease, anxiety, and depression only.
Key exclusion criteria (2 listed)
- cognitive impairment as ascertained by the Mini-Mental State Exam (MMSE) score < 24 (Crum et al., 1993); cognitive impairment interferes with participants' understanding of, and ability to implement the behavioral interventions; and
- confirmed medical diagnosis and current treatment for sleep apnea as reported by participants; SCI and SRT are not recommended for sleep apnea.
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 |
|---|---|---|
| Stimulus Control Instructions and Sleep Restriction TherapyPlease refer to arm/group descriptions. | Behavioural | Sleep Restriction Therapy (SRT), Stimulus Control Instructions (SCI) |
Primary outcome
Sleep Outcome Sleep Quantity Change over time
Time frame: Sleep Quantity data will be collected at 4 time points: approximately at 2 weeks (pretest), posttest (at 5 weeks), 6-month and 12-month (1 year)
Sleep Outcomes include: sleep duration, sleep onset latency, wake after sleep onset, sleep efficiency, and daytime fatigue. The daily sleep diary (DSD) will be completed by participants to assess sleep quantity. The DSD is a self-administered log of nightly sleep behaviors. The DSD was developed by Morin (1993).
Sleep Outcome: Sleep Quality change over time
Time frame: Sleep Quality data will be collected at 4 time points: at 2 weeks (pretest), posttest (at 5 weeks), 6-month and 12-month (1 year)
Insomnia Severity Index (ISI)
3 secondary outcomes
Psychological Outcomes: Anxiety change over time
Time frame: Psychological Outcome data will be collected at 4 time points: at 2 weeks (pretest), posttest (at 5 weeks), 6-month and 12-month (1 year)
Psychological Outcomes: Depression change over time
Time frame: Psychological Outcome data will be collected at 4 time points: at 2 weeks (pretest), posttest (at 5 weeks), 6-month and 12-month (1 year)
Physical Outcomes: Cardiovascular Symptoms and Events Change over time
Time frame: Physical Outcome data will be collected at 4 time points: at 2 weeks (pretest), posttest (at 5 weeks), and 6-month and 12-month follow-up (1 year).
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 31 Jul 2015.
- Results publicationIbrahim S, Sidani S. Preferences for behavioral therapies for chronic insomnia. Health 5(11): 1784-1790, 2013.
- Derived from this study: PubMed 26557787Sidani S, Fox M, Streiner DL, Miranda J, Fredericks S, Epstein DR. Examining the influence of treatment preferences on attrition, adherence and outcomes: a protocol for a two-stage partially randomized trial. BMC Nurs. 2015 Nov 9;14:57. doi: 10.1186/s12912-015-0108-4. eCollection 2015.
- Related InfoLink provided by the sponsor.
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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.
Dr. Souraya Sidani, PhD principal investigator
Toronto Metropolitan University
Questions about this trial
What is this clinical trial studying?
A study of Insomnia and Cardiovascular Disease, run by Toronto Metropolitan University.
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 2 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 31 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Sleep Outcome Sleep Quantity Change over time (time frame: Sleep Quantity data will be collected at 4 time points: approximately at 2 weeks (pretest), posttest (at 5 weeks), 6-month and 12-month (1 year)). 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?
On the ClinicalTrials.gov record for NCT02513017, which also lists 2 linked publications.
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 31 Jul 2015.