Obstructive Sleep Apnea of AdultNCT04262960
Effect of Continuous Positive Airway Pressure on Chronotype, Dietary Intake, and Cardiovascular Risk Markers
A study testing Device: active CPAP in people with Obstructive Sleep Apnea of Adult, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 75 years
- Conditions the study is for
- Obstructive Sleep Apnea of Adult
- What is being tested?
- Device: active CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2019to Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 75 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clinicas de Porto alegre
Porto Alegre, Rio Grande do Sul, 90035903
Ruy Silveira Moraes Filho, PhD, 55 51 33598289, rfilho@hcpa.edu.br
About this study
Official title: 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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea of Adult
- Being tested
- Device: active CPAP, Device: sham-CPAP
- Keywords
- Obstructive sleep apnea, Continuous positive airway pressure, Elders, Chronotype, Cardiovascular risk, Food intake
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: active CPAPDevice
auto-PAP with pressure between 4 and 20 cm H2O will be administered to randomized patients
Device: sham-CPAPDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| active CPAP | Active comparator | auto-PAP with therapeutic pressure Receives: Device: Device: active CPAP |
| sham-CPAP | Sham comparator | auto-PAP with pressure less than 1cm H2O Receives: Device: Device: sham-CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (7)
Plasminogen activator inhibitor type 1
Plasminogen activator inhibitor type 1 (pg/mL) measured from a blood sample by ELISA.
Measured: 1 week before and two weeks after randomization
Plasminogen
Plasminogen (ng/mL) measured from a blood sample by ELISA.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 week before and two weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start1 Aug 2019
- Primary completionApr 2020 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea of AdultStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ruy Silveira Morais Filho, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04262960
- Sponsor's protocol ID
- 07034918000005327
- Status last verified
- Feb 2020
- First submitted
- 15 Jan 2020
- Last updated
- 10 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Continuous Positive Airway Pressure on Chronotype, Dietary Intake, and Cardiovascular Risk Markers of Elderly Patients With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT04262960
- Acronym / sponsor ID
- 07034918000005327
- Conditions
- Obstructive Sleep Apnea of Adult
- Keywords
- Obstructive sleep apnea, Continuous positive airway pressure, Elders, Chronotype, Cardiovascular risk, Food intake
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 10 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active CPAP | Active comparator | Device: Device: active CPAPauto-PAP with therapeutic pressure |
| sham-CPAP | Sham comparator | Device: Device: sham-CPAPauto-PAP with pressure less than 1cm H2O |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device: active CPAPauto-PAP with pressure between 4 and 20 cm H2O will be administered to randomized patients | Device | active CPAP |
| Device: sham-CPAPThe 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. | Device | sham-CPAP |
Primary outcome
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.
7 secondary outcomes
Plasminogen activator inhibitor type 1
Time frame: 1 week before and two weeks after randomization
Plasminogen
Time frame: 1 week before and two weeks after randomization
Blood pressure
Time frame: 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
Sleep habits
Time frame: 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
Autonomic modulation
Time frame: 1 week before and two weeks after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruy Silveira Morais Filho, PhD principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device: active CPAP in people with Obstructive Sleep Apnea of Adult, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruy Silveira Morais Filho, PhD (+55 5133598289, rfilho@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The association between withdrawal CPAP with chronotype, food intake pattern and cardiovascular risk markers. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2020.