Effect of CPAP vs Control on Nocturnal Dipping in Normotensive Patients With Obstructive Sleep Apnea

Study Overview
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Brief Summary
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This is an open-label, parallel, prospective, randomised control trial evaluating the effect of Continuous Positive airway pressure (CPAP), the standard treatment for obstructive sleep apnea (OSA) versus control (diet and lifestyle advice) on dipping status and blood pressure parameters in 100 non-dipper normotensive patients with moderate to severe obstructive sleep apnea and without established cardiovascular or metabolic disease.

Official Title
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The Effect of CPAP on Nocturnal Dipping in Normotensive Patients With Moderate-severe Obstructive Sleep Apnoea, a Multicentre Randomised Controlled Trial

Conditions
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Sleep Apnea, Obstructive

Intervention / Treatment
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* Device: CPAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly diagnosed moderate-severe OSA (by standard criteria) Absence of known hypertension and antihypertensive medication Office blood pressure <140/90mmHg Age 18 - 70 years Able to provide written, informed consent Exclusion Criteria: Pregnancy Previous diagnosis of OSA or previous CPAP treatment Diagnosis of Diabetes Mellitus Active treatment for malignancy or severe psychiatric disorder History of cardiovascular disease or cerebrovascular disease Moderate or severe chronic kidney disease (CKD) defined as a eGFR of ≤ 44mL/min/1.73m2 Dipper on ABPM Morbid obesity, defined as BMI ≥40 Professional drivers or drivers with a history of road-traffic accident due to sleepiness Severe excessive daytime sleepiness defined as Epworth sleepiness scale (ESS) >15

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPAP treatment<br>This group will receive CPAP treatment | Device: CPAP<br>* Gold standard treatment for obstructive sleep apnea. In this group, patients will be prescribed CPAP treatment according to local policy.<br>|
| No Intervention: Control<br>This group will receive Diet and Lifestyle advice only | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Dipping status | Change in % dipping after 3 months of treatment with CPAP versus Control | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the mean 24-hour ambulatory blood pressure (BP) | Change in mmHg in mean blood pressure from baseline to 12 weeks of treatment compared to control | 3 months | 
| Change in blood pressure parameters | Change in mmHg in blood pressure parameters including diurnal and nocturnal systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline to 12 weeks of treatment compared to control | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Continuous positive airway pressure, Non-dipper, Normotensive