Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04262960
Recruitment Status : Recruiting
First Posted : February 10, 2020
Last Update Posted : February 10, 2020
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea of Adult Device: Device: active CPAP Device: Device: sham-CPAP Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Plasminogen [ Time Frame: 1 week before and two weeks after randomization ]
    Plasminogen (ng/mL) measured from a blood sample by ELISA.

  3. 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.

  4. 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).

  5. 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.

  6. 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.

  7. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years to 75 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Ruy Silveira Morais Filho, PhD +55 5133598289 rfilho@hcpa.edu.br
Contact: Lisette Redondo cotes 55 5133598289 lisetteredondo@gmail.com

Locations
Layout table for location information
Brazil
Hospital de Clinicas de Porto alegre Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90035903
Contact: Ruy Silveira Moraes Filho, PhD    55 51 33598289    rfilho@hcpa.edu.br   
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Layout table for investigator information
Principal Investigator: Ruy Silveira Morais Filho, PhD Hospital de Clinicas de Porto Alegre

Layout table for additonal information
Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT04262960    
Other Study ID Numbers: 07034918000005327
First Posted: February 10, 2020    Key Record Dates
Last Update Posted: February 10, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital de Clinicas de Porto Alegre:
Obstructive sleep apnea
Continuous positive airway pressure
Elders
Chronotype
Cardiovascular risk
Food intake
Additional relevant MeSH terms:
Layout table for MeSH terms
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases