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

NCT ID: NCT04262960

Last Updated: 2020-02-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2021-04-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

active CPAP

auto-PAP with therapeutic pressure

Group Type: ACTIVE_COMPARATOR

Device: active CPAP

Intervention Type: DEVICE

auto-PAP with pressure between 4 and 20 cm H2O will be administered to randomized patients

sham-CPAP

auto-PAP with pressure less than 1cm H2O

Group Type: SHAM_COMPARATOR

Device: sham-CPAP

Intervention Type: DEVICE

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.

Interventions

Device: active CPAP

auto-PAP with pressure between 4 and 20 cm H2O will be administered to randomized patients

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age 65 to 75 years
• Previous diagnosis of OSA with AHI> 30 events / hour
• Body mass index below 34,9 kg/m2
• Use of CPAP for more than one year, with an average duration of at least 6 hours per night, confirmed by the device's memory
• Evidence in the device that you have stopped using it previously, for at least two weeks, with no relevant symptoms
• Use of automatic CPAP device with full memory for at least one year, preferably using device model with internet data access
• Subjects physically active and willing to provide informed consent
• Subjects willing to attend visits and blood collections in series

Exclusion Criteria

• History of myocardial infarction, stroke or transient ischemic attack (TIA) or peripheral vascular disease.
• History of chronic diseases such as diabetes mellitus ( A fasting plasma glucose (FPG) level of 152 mg/dL or A1C > 7,5 % ), uncontrolled severe hypertension (SBP >180 DBP > 110), renal failure on dialysis, cancer, autoimmune or liver disease
• A significant history of medical or psychiatric disease that may decompensate with altered sleep patterns or impair participation in the trial
• Severe or unstable clinical conditions that may be exacerbated by discontinuation of CPAP (cardiac, pulmonary, renal or other organ disorders not yet treated or worsening of symptoms in the last two months, eg cardiac arrhythmias, congestive heart failure and oxygen-dependent lung disease)
• Another primary sleep disorder that requires intervention with medications.
• Patients with unusual sleep or wake habits, including shift work.
• Professional driver or who crosses paths of more than one hour driving, in which the s sleepiness can be risk of accident.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ruy Silveira Morais Filho, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clinicas de Porto Alegre

Locations

Hospital de Clinicas de Porto alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Ruy Silveira Morais Filho, PhD

Role: CONTACT

rfilho@hcpa.edu.br

+55 5133598289

Lisette Redondo cotes

Role: CONTACT

lisetteredondo@gmail.com

55 5133598289

Facility Contacts

Ruy Silveira Moraes Filho, PhD

Role: primary

rfilho@hcpa.edu.br

55 51 33598289

Other Identifiers

07034918000005327

Identifier Type: -

Identifier Source: org_study_id