The aim of this study is to evaluate the efficacy of a combination of Continuous Positive Airway Pressure (CPAP) and a Mandibular Advancement Device (MAD) on nocturnal Blood Pressure control in hypertensive patients in obstructive sleep apnea low CPAP compliers (less than 4 hours per night). Hypertensive patients demonstrating low CPAP adherence will be selected during a screening visit; they will be then randomized to one of the three following arms: Education to CPAP ("CPAP only"), Treatment by a MAD ("MAD only") or a combination of both CPAP and MAD ("CPAP+MAD"). Mean systolic, diastolic, diurnal and nocturnal blood pressure will be assessed during 24-h Ambulatory Blood Pressure monitoring, before and after a 3-month treatment intervention. Biological laboratory parameters, patients reported outcomes (daytime sleepiness and Quality of Life), will also be evaluated before and after 3 months of treatment.
The aim of this study is to test the efficacy of a combination of Continuous Positive Airway Pressure (CPAP) treatment and a Mandibular Advancement Device (MAD) on the control of nocturnal Blood Pressure over a 3-month period in hypertensive obstructive sleep apnea being low CPAP compliers. This is a prospective, randomized, open-label and multi-centric study. The investigators plan to include 105 hypertensive patients demonstrating low CPAP adherence (less than 4 hours per night). Patients will be randomly assigned to one of the following treatments: Education for improving CPAP adherence ('CPAP Only' group: patients will continue their CPAP treatment and be supported by regular coaching aimed at increasing their compliance to treatment); Mandibular Advancement Device ('MAD Only' group: patients will switch their treatment from CPAP to a MAD); a combination of CPAP and MAD ('CPAP + MAD' group: patients will be treated by both devices used simultaneously). The duration of the study is 3 months. At the selection visit, patients will undergo a polysomnography/respiratory polygraphy followed by 24h- Ambulatory Blood Pressure Monitoring, PROMs (Quality of Life, Epworth Sleepiness Score) and a blood sample for biological parameters analysis. Patients will be then randomized to one of the three groups. Patients assigned to the 'CPAP only group' will be contacted by the homecare provider to arrange coaching sessions in order to improve their compliance to CPAP (phone calls and/or home visits). Patients assigned to the 'MAD Only group' will be proposed a Mandibular Advancement Device. Patients assigned to the 'CPAP+MAD group' will have both CPAP (with coaching) and a MAD. After a 3-month treatment period, the same measurements (24h-Ambulatory Blood pressure, polysomnography/respiratory polygraphy, questionnaires, and blood sample analysis) will be repeated to compare efficacy of the 3 interventions. Tolerance (number of adverse events) and adherence to treatments will also be assessed. The 'CPAP+MAD' group will be compared to the other two groups in order to evaluate the benefit of the combination therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Mask connected to a pump (CPAP machine) that forces air into the nasal passages at pressures high enough to overcome obstructions in the airways. Plus patient education.
Adjustable oral prosthesis which retains the lower mandible in an anterior position, thus limiting sleep apneas
Nouvelle Clinique Bel Air
Bordeaux, France
University Hospital Grenoble
Grenoble, France
University Hospital Montpellier
Montpellier, France
Cabinet Médical
Perpignan, France
Nightime Mean Blood Pressure
Difference in nighttime Mean Blood Pressure before and after treatment, measured by ambulatory blood pressure
Time frame: 3 months
Other 24h ambulatory blood pressure measurements
24h ambulatory blood pressure measurements (systolic, diastolic and mean, diurnal and nocturnal) before and after treatment
Time frame: 3 months
Blood Pressure Variability
Blood Pressure variability before and after treatment, measured by ambulatory blood pressure measurements
Time frame: 3 months
Percent Dippers/dipping phenotypes
Percentage of dipper patients (\>10% drop in nocturnal Blood Pressure compared with daytime BP)
Time frame: 3 months
3-days home Blood Pressure measurements (systolic, diastolic)
self-measurement of Systolic and Diastolic Blood Pressure, measured over 3 days, twice a day, before and after interventions
Time frame: 3 months
Epworth Score
Score on the Epworth Sleepiness Questionnaire, before and after treatment. The ESS is a self-administered questionnaire with 8 questions. Patients are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The ESS score (the sum of 8 sub-item scores( 0-3) can range from 0 to 24. The higher the ESS score the greater the likelihood that the person has daytime sleepiness.
Time frame: 3 months
Quality of Life score
Score on the Quality Of Life Questionnaire SF12, before and after treatment. The SF-12 is a self-administered short survey with 12 questions assessing quality of life. The questions are combined, scored, and weighted to create two subscales (mental and social score and physical score) that provide glimpses into health-related quality of life. The lower the scores the more disability.
Time frame: 3 months
Serum concentration of Cholesterol
Serum concentration of low-density lipoprotein cholesterol (LPL-C) and high-density lipoprotein cholesterol (HDL-C), before and after treatment.
Time frame: 3 months
Serum concentration of Triglycerides
Serum concentration of Triglyceride, before and after treatment
Time frame: 3 months
Concentration of fasting Glucose
Concentration of fasting glucose, before and after treatment
Time frame: 3 months
Amount of HbA1C
Amount of HbA1c, before and after treatment
Time frame: 3 months
Incidence of adverse events related to the treatment
Number of adverse events related to the treatment during the 3-month period
Time frame: 3 months
Compliance to treatment(s)
Use of the device(s) defined by number of hour per night and number of night per week
Time frame: 3 months
Efficacy determined by comparison of Apnea-Hypopnea Index (AHI), number of central and obstructive apneas and hypopneas, before and after treatment
AHI, central and obstructive apneas and hyponeas index, measured by polysomnography or polygraphy, before and after treatment
Time frame: 3 months
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