NCT04262960

Effect of Continuous Positive Airway Pressure on Chronotype, Dietary Intake, and Cardiovascular Risk Markers

Effect of Continuous Positive Airway Pressure on Chronotype, Dietary Intake, and Cardiovascular Risk Markers of Elderly Patients With Obstructive Sleep Apnea

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Hospital de Clinicas de Porto Alegre · Academic / Other
• Sex: All
• Age: 65 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

In this study the investigators will evaluate chronotype, food intake pattern, and cardiovascular risk markers of elder individuals with OSA, in use of CPAP, when submitted to two weeks of CPAP withdrawal.

Detailed description

Obstructive sleep apnea (OSA) is a growing public health problem affecting up to 95% of older populations. This sleep disorder influences glucose metabolism, leptin and grelin levels, promotes sympathetic overactivity, and is associated to increased cardiovascular events. All awake-sleep processes are determined by clock-genes and by external factors such as sunlight, physical activity, feeding, sleep, and chronotype. Chronotype is the propensity for the individual to wake and sleep at a particular time during a 24-hour period, and is categorized as morning, intermediate or evening chronotype. Individuals with morning chronotype are more alert in the morning and choose an earlier bedtime. Individuals with evening chronotype have more inclination for evening activities and choose a later bedtime. And those classified as intermediate chronotype show low or no preference for either morning or evening hours for activities. Individuals with evening chronotype tend to have higher nocturnal food intake, body mass index (BMI), levels of stress hormones, and more sleep apnea episodes. In humans, changes in sleep pattern for a few days are sufficient to affect food intake pattern. Two days of partial sleep deprivation increases hunger and appetite for calorie-dense foods with high carbohydrate content. Food composition, quantity, timing, and rhythmicity of meals impact on microbiota and metabolism, increasing basal level of inflammation and age related diseases. The aging process comes with an increase in the molecules involved in hypercoagulable states, such as plasminogen activator inhibitor 1 (PAI-1), a protein induced by inflammatory mediators, which creates a prothrombotic state, resulting in a pathological deposit of fibrin followed by tissue damage. The increase in PAI-1 expression is related to the development of tissue pathologies such as thrombosis, fibrosis and cardiovascular disease. Adults with moderate-to-severe OSA have higher levels of PAI-1, and respond to two weeks of Continuous Positive Airway Pressure (CPAP) with a 50% reduction in this antifibrinolytic enzyme. The impact of CPAP use on chronotype, food intake pattern, and cardiovascular risk markers have never been studied in elder individuals with OSA.

Conditions

• Obstructive Sleep Apnea of Adult

Interventions

Type	Name	Description
DEVICE	Device: active CPAP	auto-PAP with pressure between 4 and 20 cm H2O will be administered to randomized patients
DEVICE	Device: sham-CPAP	The sham-CPAP will be fixed in the lowest pressure (4cmH2) and modified as recommended by Farré et al, with pressure that no greater than 1cm H2O.

Timeline

• Start date: 2019-08-01
• Primary completion: 2020-04-01
• Completion: 2021-04-01
• First posted: 2020-02-10
• Last updated: 2020-02-10

Locations

1 site across 1 country: Brazil