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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active CPAP | Active Comparator | auto-PAP with therapeutic pressure |
|
| sham-CPAP | Sham Comparator | auto-PAP with pressure less than 1cm H2O |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Device: active CPAP | Device | auto-PAP with pressure between 4 and 20 cm H2O will be administered to randomized patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| The association between withdrawal CPAP with chronotype, food intake pattern and cardiovascular risk markers. | Chronotype as defined by the MEQ chronotype categories; food intake pattern dietary assessed by a 3 day food intake diary, and Plasminogen activator inhibitor type 1 (pg/mL) and plasminogen (ng/mL) measured from blood samples by ELISA. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Plasminogen activator inhibitor type 1 | Plasminogen activator inhibitor type 1 (pg/mL) measured from a blood sample by ELISA. | 1 week before and two weeks after randomization |
| Plasminogen | Plasminogen (ng/mL) measured from a blood sample by ELISA. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruy Silveira Morais Filho, PhD | Contact | +55 5133598289 | rfilho@hcpa.edu.br | |
| Lisette Redondo cotes | Contact | 55 5133598289 | lisetteredondo@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ruy Silveira Morais Filho, PhD | Hospital de Clinicas de Porto Alegre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Clinicas de Porto alegre | Recruiting | Porto Alegre | Rio Grande do Sul | 90035903 | Brazil |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| Device: sham-CPAP | 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. |
|
| 1 week before and two weeks after randomization |
| Blood pressure | We will be measuring Systolic and Diastolic Blood Pressure by Ambulatory 24-hour blood pressure monitoring. | 1 week before and two weeks after randomization |
| Chronotype | Morningness Eveningness Questionaire (MEQ) inquires about daily performance and preferred sleep schedule (score range 16 to 86) and presents 19 questions. Based on their scores, individuals will be classified as morning (score: 50-86) or evening type (score: 16-49). | 1 week before and 1 week after randomization - MEQ 1 week before and 2 weeks after randomization |
| Sleep habits | Sleeping and awake periods will be assessed by a wrist actigraphy monitor (ActTrust, Condor Instruments, São Paulo - Brazil) according to the Cole-Kripke algorithm, and the duration expressed in minutes. | 1 week before and 1 week after randomization - MEQ 1 week before and 2 weeks after randomization |
| Dietary intake | Participants will record food intake for three consecutive days, including two days of the week and one day of the weekend. During the visit, they will receive verbal instructions on how to register, as well as written instructions consisting of printed material showing the portion sizes of the food and how to fill the journal. Information about mealtimes will also be obtained. Data will be analyzed using a Brazilian Nutrition Software (Dietbox) and expressed in calories an in percentage of total caloric intake. A meal will be considered as an occasion to eat when consumption exceeds 20 kcal. Higher caloric intake in the evening will be associated to evening chronotype. | For three days before and after randomization |
| Autonomic modulation | Autonomic modulation will be evaluated by low frequency (LF) and high frequency (HF) components of heart rate spectral analysis, at rest and during sympathetic stimulation with the Stroop Color Word Test, expressed in ms2/Hz and in normalized units. The amount of increase in LF/HF ratio during sympathetic stimulation will reflect the autonomic modulation integrity. | 1 week before and two weeks after randomization |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |