Effect of Continuous Positive Airway Pressure on Chronotype, Dietary Intake, and Cardiovascular Risk Markers
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|ClinicalTrials.gov Identifier: NCT04262960|
Recruitment Status : Recruiting
First Posted : February 10, 2020
Last Update Posted : February 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea of Adult||Device: Device: active CPAP Device: Device: sham-CPAP||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Effect of Continuous Positive Airway Pressure on Chronotype, Dietary Intake, and Cardiovascular Risk Markers of Elderly Patients With Obstructive Sleep Apnea|
|Actual Study Start Date :||August 1, 2019|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2021|
Active Comparator: active CPAP
auto-PAP with therapeutic pressure
Device: Device: active CPAP
auto-PAP with pressure between 4 and 20 cm H2O will be administered to randomized patients
Sham Comparator: sham-CPAP
auto-PAP with pressure less than 1cm H2O
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.
- The association between withdrawal CPAP with chronotype, food intake pattern and cardiovascular risk markers. [ Time Frame: 4 weeks ]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.
- Plasminogen activator inhibitor type 1 [ Time Frame: 1 week before and two weeks after randomization ]Plasminogen activator inhibitor type 1 (pg/mL) measured from a blood sample by ELISA.
- Plasminogen [ Time Frame: 1 week before and two weeks after randomization ]Plasminogen (ng/mL) measured from a blood sample by ELISA.
- Blood pressure [ Time Frame: 1 week before and two weeks after randomization ]We will be measuring Systolic and Diastolic Blood Pressure by Ambulatory 24-hour blood pressure monitoring.
- Chronotype [ Time Frame: 1 week before and 1 week after randomization - MEQ 1 week before and 2 weeks after randomization ]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).
- Sleep habits [ Time Frame: 1 week before and 1 week after randomization - MEQ 1 week before and 2 weeks after randomization ]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.
- Dietary intake [ Time Frame: For three days before and after randomization ]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.
- Autonomic modulation [ Time Frame: 1 week before and two weeks after randomization ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04262960
|Contact: Ruy Silveira Morais Filho, PhD||+55 firstname.lastname@example.org|
|Contact: Lisette Redondo cotes||55 email@example.com|
|Hospital de Clinicas de Porto alegre||Recruiting|
|Porto Alegre, Rio Grande Do Sul, Brazil, 90035903|
|Contact: Ruy Silveira Moraes Filho, PhD 55 51 33598289 firstname.lastname@example.org|
|Principal Investigator:||Ruy Silveira Morais Filho, PhD||Hospital de Clinicas de Porto Alegre|