Emory University
Atlanta, Georgia, 30322, United States
NCT Number: NCT02299193
The purpose of this study is to compare the effect of 6-weekly, 20 minute sessions of 2 online behavioral sleep interventions (cognitive behavioral therapy or healthy sleep habits) on blood pressure, sleep, depressive symptoms and anxiety in people with insomnia and prehypertension or hypertension.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Atlanta, Georgia, 30322, United States
Approximately 30% of US adults have prehypertension (untreated blood pressure ≥120-139/80-89 mmHg) and 29% have hypertension (blood pressure ≥ 140/90 mmHg or antihypertensive medication use). Numerous factors contribute to the development of prehypertension and hypertension including age, genetics, obesity, and behavioral factors such as exercise and diet.However, the sleep disorder insomnia is another behavioral factor increasingly implicated with risk of hypertension. Insomnia, the most frequent sleep complaint in adults, is characterized by difficulty falling asleep, trouble maintaining sleep or non-restorative sleep coupled with significant daytime distress or functional impairment. Insomnia is a pervasive sleep disorder associated with decreased quality of life, reduced work productivity, and increased health care costs; it is increasingly identified as a cardiovascular disease risk factor. Lifestyle modifications recommended for pre-hypertension and hypertension do not address sleep. This pilot randomized clinical trial will test the preliminary efficacy of an online cognitive behavioral therapy intervention (N=40) versus an online healthy sleep habits intervention (N=20), to reduce blood pressure in a sample of untreated individuals with insomnia and prehypertension or hypertension. Participants will be followed for 12-weeks post-intervention. Primary outcome measures are systolic blood pressure. Secondary measures include sleep efficiency, insomnia severity, physical and mental function.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
6 weekly, 20 minute online sessions about how thoughts and behaviors can affect sleep
Other names: CBT-I
6 weekly, 20 minute online sessions about healthy sleep practices
Time frame: 8 and 20 weeks
Systolic blood pressure will be measured at baseline, 8 and 20 weeks
Time frame: 8 and 20 weeks
Insomnia Severity Index (ISI) questionnaire will be measured at baseline, 8 and 20 weeks
Time frame: 8 and 20 weeks
Actigraphy based sleep efficiency will be measured at baseline, 8 and 20 weeks
Time frame: 8 and 20 weeks
Depressive symptoms measured at baseline, 8 and 20 weeks
Time frame: 8 and 20 weeks
Mental function measured at baseline, 8 and 20 weeks
Emory University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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