Effect of Continuous Positive Airway Pressure on Chronotype, Dietary Intake, and Cardiovascular Risk Markers
Primary Purpose
Obstructive Sleep Apnea of Adult
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Device: active CPAP
Device: sham-CPAP
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea of Adult focused on measuring Obstructive sleep apnea, Continuous positive airway pressure, Elders, Chronotype, Cardiovascular risk, Food intake
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.
Sites / Locations
- Hospital de Clinicas de Porto alegreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
active CPAP
sham-CPAP
Arm Description
auto-PAP with therapeutic pressure
auto-PAP with pressure less than 1cm H2O
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Plasminogen activator inhibitor type 1
Plasminogen activator inhibitor type 1 (pg/mL) measured from a blood sample by ELISA.
Plasminogen
Plasminogen (ng/mL) measured from a blood sample by ELISA.
Blood pressure
We will be measuring Systolic and Diastolic Blood Pressure by Ambulatory 24-hour blood pressure monitoring.
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).
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.
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.
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.
Full Information
NCT ID
NCT04262960
First Posted
January 15, 2020
Last Updated
February 6, 2020
Sponsor
Hospital de Clinicas de Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT04262960
Brief Title
Effect of Continuous Positive Airway Pressure on Chronotype, Dietary Intake, and Cardiovascular Risk Markers
Official Title
Effect of Continuous Positive Airway Pressure on Chronotype, Dietary Intake, and Cardiovascular Risk Markers of Elderly Patients With Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
April 2020 (Anticipated)
Study Completion Date
April 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea of Adult
Keywords
Obstructive sleep apnea, Continuous positive airway pressure, Elders, Chronotype, Cardiovascular risk, Food intake
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
active CPAP
Arm Type
Active Comparator
Arm Description
auto-PAP with therapeutic pressure
Arm Title
sham-CPAP
Arm Type
Sham Comparator
Arm Description
auto-PAP with pressure less than 1cm H2O
Intervention Type
Device
Intervention Name(s)
Device: active CPAP
Intervention Description
auto-PAP with pressure between 4 and 20 cm H2O will be administered to randomized patients
Intervention Type
Device
Intervention Name(s)
Device: sham-CPAP
Intervention Description
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.
Primary Outcome Measure Information:
Title
The association between withdrawal CPAP with chronotype, food intake pattern and cardiovascular risk markers.
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Plasminogen activator inhibitor type 1
Description
Plasminogen activator inhibitor type 1 (pg/mL) measured from a blood sample by ELISA.
Time Frame
1 week before and two weeks after randomization
Title
Plasminogen
Description
Plasminogen (ng/mL) measured from a blood sample by ELISA.
Time Frame
1 week before and two weeks after randomization
Title
Blood pressure
Description
We will be measuring Systolic and Diastolic Blood Pressure by Ambulatory 24-hour blood pressure monitoring.
Time Frame
1 week before and two weeks after randomization
Title
Chronotype
Description
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).
Time Frame
1 week before and 1 week after randomization - MEQ 1 week before and 2 weeks after randomization
Title
Sleep habits
Description
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.
Time Frame
1 week before and 1 week after randomization - MEQ 1 week before and 2 weeks after randomization
Title
Dietary intake
Description
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.
Time Frame
For three days before and after randomization
Title
Autonomic modulation
Description
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.
Time Frame
1 week before and two weeks after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ruy Silveira Morais Filho, PhD
Phone
+55 5133598289
Email
rfilho@hcpa.edu.br
First Name & Middle Initial & Last Name or Official Title & Degree
Lisette Redondo cotes
Phone
55 5133598289
Email
lisetteredondo@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruy Silveira Morais Filho, PhD
Organizational Affiliation
Hospital de Clinicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clinicas de Porto alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035903
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruy Silveira Moraes Filho, PhD
Phone
55 51 33598289
Email
rfilho@hcpa.edu.br
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Continuous Positive Airway Pressure on Chronotype, Dietary Intake, and Cardiovascular Risk Markers
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