Condition or disease | Intervention/treatment | Phase |
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Hypertension Insomnia | Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 150 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | All participants will receive the Cognitive Behavioral Therapy for Insomnia |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | Sleep Quality and Mechanisms of Cardiovascular Risks in Adults With Hypertension |
Actual Study Start Date : | February 14, 2020 |
Estimated Primary Completion Date : | June 2024 |
Estimated Study Completion Date : | June 2024 |
Arm | Intervention/treatment |
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Cognitive Behavioral Therapy for Insomnia
Cognitive Behavioral Therapy for Insomnia (CBT-I) 6 sessions of Cognitive Behavioral Training for Insomnia (1 hour each).
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Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)
6-week CBT-I therapy to help improve sleep quality
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Ages Eligible for Study: | 30 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kristy Johnson, MPH | 919-681-5874 | johns121@mc.duke.edu | |
Contact: Andrew Sherwood, PhD | 919-684-8835 | sherw002@mc.duke.edu |
United States, North Carolina | |
Duke University Medical Center | Recruiting |
Durham, North Carolina, United States, 27710 | |
Principal Investigator: Andrew Sherwood, PhD | |
Duke University Medical Center | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: Kristy S Johnson, MPH 919-681-5874 johns121@mc.duke.edu | |
Contact: Andrew Sherwood, PhD 919-684-8835 sherw002@mc.duke.edu | |
Principal Investigator: Andrew Sherwood, PhD |
Principal Investigator: | Andrew Sherwood, PhD | Duke University |
Tracking Information | |||||||||
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First Submitted Date ICMJE | July 3, 2019 | ||||||||
First Posted Date ICMJE | July 5, 2019 | ||||||||
Last Update Posted Date | March 10, 2021 | ||||||||
Actual Study Start Date ICMJE | February 14, 2020 | ||||||||
Estimated Primary Completion Date | June 2024 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Sleep Quality and Mechanisms of Cardiovascular Risks in Adults With Hypertension | ||||||||
Official Title ICMJE | Sleep Quality and Mechanisms of Cardiovascular Risks in Adults With Hypertension | ||||||||
Brief Summary | The objective of this study is to elucidate the potential mechanisms responsible for the increased risk of cardiovascular disease among patients with hypertension and comorbid insomnia. | ||||||||
Detailed Description | The investigators propose to utilize a behavioral intervention to manipulate sleep quality in 150 adults with hypertension and comorbid insomnia, who will receive a 6-week Cognitive Behavioral therapy for Insomnia (CBT-I) intervention, which has been shown to markedly improve sleep quality and promote consolidated sleep in approximately 60% of those treated. A lowering of nighttime blood pressure is one of several proposed mechanisms to be examined. | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: All participants will receive the Cognitive Behavioral Therapy for Insomnia Masking: None (Open Label)Primary Purpose: Other |
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Condition ICMJE |
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Intervention ICMJE | Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)
6-week CBT-I therapy to help improve sleep quality
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Study Arms ICMJE | Cognitive Behavioral Therapy for Insomnia
Cognitive Behavioral Therapy for Insomnia (CBT-I) 6 sessions of Cognitive Behavioral Training for Insomnia (1 hour each).
Intervention: Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
150 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | June 2024 | ||||||||
Estimated Primary Completion Date | June 2024 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 30 Years to 60 Years (Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT04009447 | ||||||||
Other Study ID Numbers ICMJE | PRO00102036 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Duke University | ||||||||
Study Sponsor ICMJE | Duke University | ||||||||
Collaborators ICMJE | National Institutes of Health (NIH) | ||||||||
Investigators ICMJE |
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PRS Account | Duke University | ||||||||
Verification Date | March 2021 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |