- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04262960
Effect of Continuous Positive Airway Pressure on Chronotype, Dietary Intake, and Cardiovascular Risk Markers
February 6, 2020 updated by: Hospital de Clinicas de Porto Alegre
Effect of Continuous Positive Airway Pressure on Chronotype, Dietary Intake, and Cardiovascular Risk Markers of Elderly Patients With Obstructive Sleep Apnea
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
44
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ruy Silveira Morais Filho, PhD
- Phone Number: +55 5133598289
- Email: rfilho@hcpa.edu.br
Study Contact Backup
- Name: Lisette Redondo cotes
- Phone Number: 55 5133598289
- Email: lisetteredondo@gmail.com
Study Locations
-
-
Rio Grande Do Sul
-
Porto Alegre, Rio Grande Do Sul, Brazil, 90035903
- Recruiting
- Hospital de Clinicas de Porto Alegre
-
Contact:
- Ruy Silveira Moraes Filho, PhD
- Phone Number: 55 51 33598289
- Email: rfilho@hcpa.edu.br
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 75 years (OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: active CPAP
auto-PAP with therapeutic pressure
|
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 week before and two weeks after randomization
|
Plasminogen
Time Frame: 1 week before and two weeks after randomization
|
Plasminogen (ng/mL) measured from a blood sample by ELISA.
|
1 week before and two weeks after randomization
|
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.
|
1 week before and two weeks after randomization
|
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).
|
1 week before and 1 week after randomization - MEQ 1 week before and 2 weeks after randomization
|
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.
|
1 week before and 1 week after randomization - MEQ 1 week before and 2 weeks after randomization
|
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.
|
For three days before and after randomization
|
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.
|
1 week before and two weeks after randomization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ruy Silveira Morais Filho, PhD, Hospital de Clinicas de Porto Alegre
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 1, 2019
Primary Completion (ANTICIPATED)
April 1, 2020
Study Completion (ANTICIPATED)
April 1, 2021
Study Registration Dates
First Submitted
January 15, 2020
First Submitted That Met QC Criteria
February 6, 2020
First Posted (ACTUAL)
February 10, 2020
Study Record Updates
Last Update Posted (ACTUAL)
February 10, 2020
Last Update Submitted That Met QC Criteria
February 6, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07034918000005327
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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