Insomnia and Cardiovascular Diseases: Influence of Behavioral Treatments and Preferences

July 30, 2015 updated by: Souraya Sidani, Ryerson University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
204

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Persons with insomnia will be eligible for the study if they:

  1. are community-dwelling, non-institutionalized middle-aged or older adults (> 40 years of age),
  2. have the ability to read and write English (required for providing written consent), and
  3. 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.

Exclusion Criteria:

  1. 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
  2. confirmed medical diagnosis and current treatment for sleep apnea as reported by participants; SCI and SRT are not recommended for sleep apnea.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Stimulus Control Instructions (SCI)

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.
Behavioral: Stimulus Control Instructions and Sleep Restriction Therapy
Please refer to arm/group descriptions.
Experimental: Sleep Restriction Therapy (SRT)
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.
Behavioral: Stimulus Control Instructions and Sleep Restriction Therapy
Please refer to arm/group descriptions.
No Intervention: No therapy
No behavioral therapy for the management of insomnia is provided. However, a list of general recommendations and suggestions are provided to participants.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 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
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)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Anxiety will be assessed with the 20-item State Trait Anxiety Inventory (STAI).
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)
Center for Epidemiology Studies - Depression (CESD) scale
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).
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.
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ryerson University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dr. Souraya Sidani, PhD, Ryerson University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 22, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 31, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PCR - 101411

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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