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Sleep to lower elevated blood pressure: study protocol for a randomized controlled trial.

ABSTRACT: Sleep is an essential component of good physical and mental health. Previous studies have reported that poor quality sleep is associated with an increased risk of hypertension and cardiovascular disease. Hypertension is the most common and important risk factor for cardiovascular disease, and even modest reductions in blood pressure can result in significant reductions in the risk of stroke and myocardial infarction. In this trial, we will determine the efficacy of an online sleep intervention in improving blood pressure, in participants with hypertension and poor sleep quality.Randomized-controlled, two-group, parallel, blinded, single-center, Phase II trial of 134 participants. Population and recruitment: Primary prevention population of participants with hypertension (systolic blood pressure, 130 to 160 mm Hg; diastolic blood pressure, <110 mm Hg) and poor sleep quality in a community setting.Multicomponent online sleep intervention consisting of sleep information, sleep hygiene education, and cognitive behavioral therapy. Comparator: Standardized cardiovascular risk factor and lifestyle-education session (usual care).Change in mean 24-hour ambulatory systolic blood pressure between baseline and 8-week follow-up. Hypertension has been selected as the primary outcome measure because of its robust association with both poor sleep quality and cardiovascular disease.Intention-to-treat analysis by using a linear mixed model.ClinicalTrials.gov: NCT01809821, registered March 8, 2013.

SUBMITTER: McGrath ER

PROVIDER: S-EPMC4209022 | biostudies-literature | 2014 Oct

REPOSITORIES: biostudies-literature

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Sleep to lower elevated blood pressure: study protocol for a randomized controlled trial.

McGrath Emer R ER Espie Colin A CA Murphy Andrew W AW Newell John J Power Alice A Madden Sarah S Byrne Molly M O'Donnell Martin J MJ

Trials 20141009

<h4>Background</h4>Sleep is an essential component of good physical and mental health. Previous studies have reported that poor quality sleep is associated with an increased risk of hypertension and cardiovascular disease. Hypertension is the most common and important risk factor for cardiovascular disease, and even modest reductions in blood pressure can result in significant reductions in the risk of stroke and myocardial infarction. In this trial, we will determine the efficacy of an online s ...[more]

PMID: 25300874

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Project description:Previous studies have suggested that psychological interventions may be effective in reducing blood pressure. Using rigorous methodology and 24-hour monitoring of ambulatory blood pressure, we compared 2 psychological interventions with treatment using a first-line antihypertensive drug in terms of their efficacy in lowering blood pressure in patients with mild primary hypertension.In this prospective, open-label randomized controlled trial (RCT), 65 adult patients with mild, uncomplicated hypertension were randomly assigned to receive one of the following interventions for 12 weeks: (1) pharmacotherapy with hydrochlorothiazide 12.5 titrated to 25 mg/d ; (2) individualized behavioural psychotherapy, consisting of ten 1-hour sessions of stress reduction training with a psychologist; or (3) self-help psychotherapy, consisting of a 1.5-hour session with a psychologist and then daily sessions that involved reading a self-help manual and listening to an audiotape. The primary outcome measure was mean change in ambulatory blood pressure from baseline to week 12. Resting blood pressure readings were taken in the clinic, and adverse events were recorded.Monitoring of ambulatory blood pressure over 24 hours showed that hydrochlorothiazide therapy significantly reduced both systolic and diastolic blood pressure relative to baseline, and that this reduction was significantly greater than that achieved with either individualized behavioural psychotherapy or self-help psychotherapy (mean reduction [standard error; SE] -11.03 [2.53] / -6.06 [1.56] mm Hg v. -0.08 [2.38] / 0.29 [1.47] mm Hg v. -1.23 [2.83] / -0.71 [1.75] mm Hg, respectively; p = 0.01). Neither form of psychological therapy significantly lowered 24-hour ambulatory blood pressure relative to baseline.For patients with primary elevated blood pressure, 2 psychological interventions did not lower 24-hour ambulatory blood pressure, whereas hydrochlorothiazide reduced blood pressure, as expected. The findings of this RCT represent an important addition to the evidence for health care practitioners and for patients seeking psychological interventions to reduce blood pressure.

Project description:BACKGROUND:Hypertension markedly increases the risk of cardiovascular diseases and overall mortality. Lifestyle modifications, such as increased levels of physical activity, are recommended as the first line of anti-hypertensive treatment. A recent systematic review showed that isometric handgrip (IHG) training was superior to traditional endurance and strength training in lowering resting systolic blood pressure (SBP). The average length of previous IHG training studies is approximately 7.5 weeks with the longest being 10 weeks. Therefore, presently it is unknown if it is possible to further lower blood pressure levels beyond the 10-week mark. Recently, we developed a novel method for monitoring handgrip intensity using a standard Nintendo Wii Board (Wii). The primary aim of this study is to explore the effects of a 20-week IHG home training facilitated by a Wii in hypertensive older adults (50?+?years of age) on lowering SBP compared to usual care. Secondary aims are to explore if/when a leveling-off effect on SBP will occur during the 20-week intervention period in the training group and to explore adherence and potential harms related to the IHG home training. METHODS/DESIGN:Based on previous evidence, we calculated that 50 hypertensive (SBP between 140 and 179 mmHg), older adults (50?+?years of age) are needed to achieve a power of 80% or more. Participants will be randomly assigned to either an intervention >group (IHG home training?+?hypertension guidelines on lifestyle changes) or to a control group (hypertension guidelines on lifestyle changes). Participants in the intervention group will perform IHG home training (30% of maximum grip strength for a total of 8 min per day per hand) three times a week for 20 weeks. Resting blood pressure and maximal handgrip strength will be obtained by a blinded outcome assessor in both groups at specific time points (baseline, follow-up at 5, 10, 15, and 20 weeks) throughout the study. DISCUSSION:This assessor-blinded, randomized controlled trial will explore the effect of a 20-week IHG home training intervention on resting blood pressure in hypertensive older adults. In addition, the trial will report adherence and potential harms related to the IHG home training. TRIAL REGISTRATION:ClinicalTrials.gov, ID: NCT03069443 . Registered on 3 March 2017.

Project description:BackgroundIn Sub-Saharan Africa, current strategies are struggling to control the burgeoning hypertension epidemic. Dietary interventions such as inorganic nitrate or folic acid supplementation could represent promising strategies for reducing blood pressure (BP) in this setting.ObjectivesThis feasibility study explores the effects of dietary inorganic nitrate supplementation, alone or in combination with folic acid, on BP in Tanzanian adults with elevated BP in Tanzania.MethodsA placebo-controlled, double-blind, randomized controlled feasibility trial was conducted. Forty-seven middle-aged and older participants (age: 50-70 y, BMI: 26.3-29.1 kg/m2) were randomly assigned to 3 conditions for a period of 60 d: 1) high-nitrate beetroot juice (∼400 mg nitrate) and folic acid (∼5 mg folic acid) (N + F), 2) high-nitrate beetroot juice and placebo (N + P), or 3) nitrate-depleted beetroot juice and placebo (P + P). Clinic and 24-h ambulatory BP and measurements of compliance in plasma (nitrate and folate concentrations) and saliva (nitrate and nitrite) were obtained at baseline, 30 d, and 60 d.ResultsBaseline resting systolic and diastolic BP (mean ± SD) was 151.0 ± 19.4 mm Hg and 91.8 ± 11.7 mm Hg, respectively. Compliance to the interventions was high (>90%) in all groups which was confirmed by the significant increase in nitrate and folic acid concentrations in plasma and saliva samples in the treatment arms. After 60 d, 24-h systolic BP dropped by -10.8 ± 9.8 mm Hg (P < 0.001), -6.1 ± 13.2 mm Hg (P = 0.03), and -0.3 ± 9.7 mm Hg (P = 0.83) in the N + P, N + F, and P + P groups, respectively. There was a significant decrease in 24-h diastolic BP in the N + P group (-5.4 ± 5.0 mm Hg, P = 0.004), whereas changes were not significant in the N + F (-1.8 ± 8.1 mm Hg, P = 0.32) and P + P (1.6 ± 8.3 mm Hg, P = 0.43) groups.ConclusionsDietary inorganic nitrate represents a potential nutritional strategy to lessen the hypertension epidemic in Sub-Saharan Africa. These findings support the rationale for future long-term investigations exploring the efficacy of dietary nitrate for lowering BP and attenuating cardiovascular disease risk in this setting.This trial was registered at isrctn.com as ISRCTN67978523.

Project description:To determine whether clinical outcomes differed by occurrence of severe hypertension in the international CHIPS trial (Control of Hypertension in Pregnancy Study), adjusting for the interventions of "less tight" (target diastolic blood pressure [dBP] 100 mm?Hg) versus "tight" control (target dBP 85 mm?Hg). In this post-hoc analysis of CHIPS data from 987 women with nonsevere nonproteinuric preexisting or gestational hypertension, mixed effects logistic regression was used to compare the following outcomes according to occurrence of severe hypertension, adjusting for allocated group and the influence of baseline factors: CHIPS primary (perinatal loss or high-level neonatal care for >48 hours) and secondary outcomes (serious maternal complications), birth weight <10th percentile, preeclampsia, delivery at <34 or <37 weeks, platelets <100×109/L, elevated liver enzymes with symptoms, maternal length of stay ?10 days, and maternal readmission before 6 weeks postpartum. Three hundred and thirty-four (34.1%) women in CHIPS developed severe hypertension that was associated with all outcomes examined except for maternal readmission (P=0.20): CHIPS primary outcome, birth weight <10th percentile, preeclampsia, preterm delivery, elevated liver enzymes (all P<0.001), platelets <100×109/L (P=0.006), and prolonged hospital stay (P=0.03). The association between severe hypertension and serious maternal complications was seen only in less tight control (P=0.02). Adjustment for preeclampsia (464, 47.3%) did not negate the relationship between severe hypertension and the CHIPS primary outcome (P<0.001), birth weight <10th percentile (P=0.005), delivery at <37 (P<0.001) or <34 weeks (P<0.001), or elevated liver enzymes with symptoms (P=0.02). Severe hypertension is a risk marker for adverse maternal and perinatal outcomes, independent of BP control or preeclampsia co-occurrence.URL: http://pre-empt.cfri.ca/. Unique identifier: ISRCTN 71416914. URL: https://www.clinicaltrials.gov/. Unique identifier: NCT01192412.

Project description:BackgroundSleep problems in childhood have been found to be associated with memory and learning impairments, irritability, difficulties in mood modulation, attention and behavioral problems, hyperactivity and impulsivity. Short sleep duration has been found to be associated with overweight and obesity in childhood. This paper describes the protocol of a behavioral intervention planned to promote healthier sleep in infants.MethodsThe study is a 1:1 parallel group single-blinded randomized controlled trial enrolling a total of 552 infants at 3 months of age. The main eligibility criterion is maternal report of the infant's sleep lasting on average less than 15 h per 24 h (daytime and nighttime sleep). Following block randomization, trained fieldworkers conduct home visits of the intervention group mothers and provide standardized advice on general practices that promote infant's self-regulated sleep. A booklet with the intervention content to aid the mother in implementing the intervention was developed and is given to the mothers in the intervention arm. In the two days following the home visit the intervention mothers receive daily telephone calls for intervention reinforcement and at day 3 the fieldworkers conduct a reinforcement visit to support mothers' compliance with the intervention. The main outcome assessed is the between group difference in average nighttime self-regulated sleep duration (the maximum amount of time the child stays asleep or awake without awakening the parents), at ages 6, 12 and 24 months, evaluated by means of actigraphy, activity diary records and questionnaires. The secondary outcomes are conditional linear growth between age 3-12 and 12-24 months and neurocognitive development at ages 12 and 24 months.DiscussionThe negative impact of inadequate and insufficient sleep on children's physical and mental health are unquestionable, as well as its impact on cognitive function, academic performance and behavior, all of these being factors to which children in low- and middle-income countries are at higher risk. Behavioral interventions targeting mothers and young children that can be delivered inexpensively and not requiring specialized training can help prevent future issues by reducing the risk to which these children are exposed.Trial registrationClinicalTrial.gov NCT02788630 registered on 14 June 2016 (retrospectively registered).

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Sleep to lower elevated blood pressure: study protocol for a randomized controlled trial.

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Sleep to lower elevated blood pressure: study protocol for a randomized controlled trial.

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