Dataset Information

The effect of antihypertensive agents on sleep apnea: protocol for a randomized controlled trial.

ABSTRACT: Obstructive sleep apnea (OSA) and hypertension are well-known cardiovascular risk factors. Their control could reduce the burden of heart disease across populations. Several drugs are used to control hypertension, but the only consistently effective treatment of OSA is continuous positive airway pressure. The identification of a drug capable of improving OSA and hypertension simultaneously would provide a novel approach in the treatment of both diseases.This is a randomized double-blind clinical trial, comparing the use of chlorthalidone with amiloride versus amlodipine as a first drug option in patients older than 40 years of age with stage I hypertension (140 to 159/90 to 99 mmHg) and moderate OSA (15 to 30 apneas/hour of sleep). The primary outcomes are the variation of the number of apneas per hour and blood pressure measured by ambulatory blood pressure monitoring. The secondary outcomes are adverse events, somnolence scale (Epworth), ventilatory parameters and C reactive protein levels. The follow-up will last 8 weeks. There will be 29 participants per group. The project has been approved by the ethics committee of our institution.The role of fluid retention in OSA has been known for several decades. The use of diuretics are well established in treating hypertension but have never been appropriately tested for sleep apnea. As well as testing the efficacy of these drugs, this study will help to understand the mechanisms that link hypertension and sleep apnea and their treatment.ClinicalTrials.gov: NCT01896661.

SUBMITTER: Cichelero FT

PROVIDER: S-EPMC3892032 | biostudies-literature | 2014 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

The effect of antihypertensive agents on sleep apnea: protocol for a randomized controlled trial.

Cichelero Fábio Tremea FT Martinez Denis D Fuchs Sandra Costa SC Gus Miguel M Moreira Leila Beltrami LB Fuchs Flávio Danni FD

Trials 20140102

<h4>Background</h4>Obstructive sleep apnea (OSA) and hypertension are well-known cardiovascular risk factors. Their control could reduce the burden of heart disease across populations. Several drugs are used to control hypertension, but the only consistently effective treatment of OSA is continuous positive airway pressure. The identification of a drug capable of improving OSA and hypertension simultaneously would provide a novel approach in the treatment of both diseases.<h4>Methods/design</h4> ...[more]

PMID: 24382030

Similar Datasets

Project description:Obstructive sleep apnea occurs as a result of increased collapsibility of the upper airway. Overnight fluid displacement from the legs to the neck causes pharyngeal narrowing and increased apnea severity. Sodium intake is associated with apnea severity. We hypothesized that interventions that decrease bodily fluid content might reduce the severity of sleep apnea.This is a randomized clinical trial including men with an apnea-hypopnea index greater than 30 events/hour, previously diagnosed by full-night in-laboratory polysomnography. A total of 54 men will be included and randomly assigned to three groups: Diuretic (n = 18), sodium-restricted diet (n = 18), and control (n = 18). The intervention will last one week. Intention-to-treat and per-protocol analyses will be performed. The diuretic group will receive combined spironolactone 100 mg plus furosemide 20 mg daily, taken in the morning. The diet group will receive a regimen with a maximum intake of 3 g of sodium per day. The control group will receive a placebo pill and will maintain all eating habits while keeping a recall diary of their dietary behavior. The primary outcome measure will be change in apnea-hypopnea index. The secondary outcome measures will be variations of: anthropometric and bioelectrical impedance variables, office blood pressure, respiratory variables from in-home level III polysomnography, excessive daytime sleepiness, glycolipid profile, C-reactive protein, 24 h urinary variables, and adverse events.Despite the high efficacy of continuous positive airway pressure to reverse upper airway obstruction in sleep apnea, partial adherence to this form of treatment reduces its efficiency. Thus, additional forms of treating apnea need to be investigated. If the results of this proof-of-concept trial show that decreases in bodily fluid content, either by diuretic or dietary intervention, reduces the severity of sleep apnea, further investigation will be necessary before these results can be translated and adopted as an adjunct apnea therapy.clinicaltrials.gov NCT01945801.

Project description:Obstructive sleep apnea (OSA) occurs due to sleep-induced upper airway muscle relaxation resulting in increased pharyngeal collapsibility. Clinical trials have shown a favorable effect of exercise training on OSA severity in middle-aged adults. Aging is characterized by motor-unit loss. Force training may affect the whole body muscle tone. We hypothesize that interventions increasing muscle strength might propagate to motor units at the abductor pharyngeal muscles, reducing collapsibility and, hence, sleep apnea severity in elderly patients with obstructive sleep apnea.This is a randomized clinical trial including patients between 65 and 80 years of age, with obstructive sleep apnea, and an apnea-hypopnea index (AHI) between 20 and 50 events/hour, diagnosed by out-of-center in-home type III polysomnography. Forty subjects will be included and randomly assigned to two equal sized groups. The participants allocated to the intervention group will attend two sessions per week of one-hour strength training for the legs, arms, chest, back, and abdomen and the controls will receive advice on lifestyle change. The primary outcome measure of the study will be the change in apnea-hypopnea index and the secondary outcomes will be the body composition, evaluated by anthropometric and bioelectrical impedance variables; maximum dynamic force, appraised by one-repetition maximum strength test; muscle quality and thickness by ultrasound; physical function assessed by sit-to-stand test, timed up and go test, handgrip strength test. The study duration will be 12 weeks. Intention-to-treat and per-protocol analyses will be performed.The high prevalence of obstructive sleep apnea in elderly people is a public health issue. OSA is a recognized cause of cardiovascular disease and reduces quality of life due to sleepiness and fatigue. Exercise is a low-cost intervention that could help to detain the trend towards age-dependent loss of pharyngeal motor units and progressive severity of obstructive sleep apnea. Home-based strength exercises may represent a more practical approach than aerobic exercise for elderly patients. If the results confirm our hypothesis, further research on the clinical application of our findings will be warranted.ClinicalTrials.gov, NCT02742792 . Registered on 1 April 2016.

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).

Project description:Obesity is strongly associated with prevalence of obstructive sleep apnea (OSA), and weight loss has been shown to reduce disease severity.To investigate whether liraglutide 3.0?mg reduces OSA severity compared with placebo using the primary end point of change in apnea-hypopnea index (AHI) after 32 weeks. Liraglutide's weight loss efficacy was also examined.In this randomized, double-blind trial, non-diabetic participants with obesity who had moderate (AHI 15-29.9 events?h(-1)) or severe (AHI ?30 events?h(-1)) OSA and were unwilling/unable to use continuous positive airway pressure therapy were randomized for 32 weeks to liraglutide 3.0?mg (n=180) or placebo (n=179), both as adjunct to diet (500 kcal?day(-1) deficit) and exercise. Baseline characteristics were similar between groups (mean age 48.5 years, males 71.9%, AHI 49.2 events?h(-1), severe OSA 67.1%, body weight 117.6?kg, body mass index 39.1?kg?m(-2), prediabetes 63.2%, HbA1c 5.7%).After 32 weeks, the mean reduction in AHI was greater with liraglutide than with placebo (-12.2 vs -6.1 events?h(-1), estimated treatment difference: -6.1 events?h(-1) (95% confidence interval (CI), -11.0 to -1.2), P=0.0150). Liraglutide produced greater mean percentage weight loss compared with placebo (-5.7% vs -1.6%, estimated treatment difference: -4.2% (95% CI, -5.2 to -3.1%), P<0.0001). A statistically significant association between the degree of weight loss and improvement in OSA end points (P<0.01, all) was demonstrated post hoc. Greater reductions in glycated hemoglobin (HbA1c) and systolic blood pressure (SBP) were seen with liraglutide versus placebo (both P<0.001). The safety profile of liraglutide 3.0?mg was similar to that seen with doses ?1.8?mg.As an adjunct to diet and exercise, liraglutide 3.0?mg was generally well tolerated and produced significantly greater reductions than placebo in AHI, body weight, SBP and HbA1c in participants with obesity and moderate/severe OSA. The results confirm that weight loss improves OSA-related parameters.

Dataset Information

The effect of antihypertensive agents on sleep apnea: protocol for a randomized controlled trial.

Publications

The effect of antihypertensive agents on sleep apnea: protocol for a randomized controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets