Obstructive Sleep Apnea of Adult Clinical Trial
Official title:
Acute, Intermediate and Long-term Effects of CPAP Therapy in Obstructive Sleep Apnoea: a Two-phase Interventional Trial.
Two-phase interventional non-inferiority trial (phase 1: at least 8 weeks of CPAP; phase 2: 2 weeks of CPAP withdrawal) including 32 patients with moderate to severe OSA to compare the physiological consequences of a short-term CPAP withdrawal to the changes in previously untreated OSA. The trial has been designed as a validation of the CPAP-withdrawal model. Baseline in-laboratory sleep studies will be performed prior to CPAP initiation, after 6-8 weeks on CPAP (treatment effect) and following 2 weeks of CPAP therapy withdrawal (withdrawal effect, effect of OSA recurrence).
Status | Recruiting |
Enrollment | 32 |
Est. completion date | December 2024 |
Est. primary completion date | July 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age = 18 years - Untreated moderate or severe OSA with an apnoea-hypopnoea-index (AHI) of = 20/h and an oxygen desaturation index (>3%-dips) of = 20/h in an in-laboratory sleep study - Epworth Sleepiness Scale Score =7/24 points - Indication for CPAP therapy - Written informed consent Exclusion Criteria: - Moderate or more severe obstructive or restrictive ventilatory disorder (FEV1 or FVC < 70%) - Heart failure - Other types of sleep-related breathing disorders, e.g. sleep-associated hypoventilation, central sleep apnoea, Cheyne Stoke's Breathing - Hypoxic or hypercapnic respiratory failure (awake paO2 < 9 kPa or paCO2 > 6 kPa) - Active treatment for OSA (CPAP, mandibular advancement device, hypoglossal nerve stimulation) - Current professional driver or previous sleepiness-related accidents - Pregnancy |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital Zurich | Zurich |
Lead Sponsor | Collaborator |
---|---|
University of Zurich |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Nocturnal systolic blood pressure | Ambulatory blood pressure monitoring (ABPM) | at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal | |
Primary | Epworth Sleepines Scale Score (ESS) | Subjective sleepiness, ESS min-max 0-24 points and ESS >10 indicating pathological daytime sleepiness | at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal | |
Secondary | 48h, 24h, diurnal and nocturnal systolic and diastolic blood pressure | ABPM | at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal | |
Secondary | Office systolic and diastolic blood pressure | Morning office blood pressure | at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal | |
Secondary | 48h, 24h, diurnal, nocturnal and office heart rate | Heart rate from ABPM, office measurement and from sleep studies | at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal | |
Secondary | Heart rate variability in the time and frequency domain (CV, RMSSD, pRR50, LF, HF, LF/HF) | Measures of heart rate variability (daytime and nighttime) | at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal | |
Secondary | Blood pressure variability (BPV, systolic and diastolic) | BPV from ABPM and beat-to-beat blood pressure measurement | at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal | |
Secondary | Baroreflex sensitivity (BRS) | Finometer | at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal | |
Secondary | Arterial stiffness | ABPM | at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal | |
Secondary | Measures of nocturnal hypoventilation (median and maximal transcutaneous partial pressure of CO2 = tcpCO2) | Sleep study parameters | at baseline and at least 8 weeks of CPAP as well as after 2 weeks of CPAP withdrawal | |
Secondary | Measures of nocturnal hypoxaemia (mean nocturnal oxygen saturation = ¢SpO2) | Sleep study parameters | at baseline and at least 8 weeks of CPAP as well as after 2 weeks of CPAP withdrawal | |
Secondary | Measures of nocturnal hypoxaemia (time spent with SpO2 below 90% = t<90) | Sleep study parameters | at baseline and at least 8 weeks of CPAP as well as after 2 weeks of CPAP withdrawal | |
Secondary | Measures of nocturnal hypoxaemia (hypoxic burden) | Sleep study parameters | at baseline and at least 8 weeks of CPAP as well as after 2 weeks of CPAP withdrawal | |
Secondary | Measures of OSA severity (apnoea-hypopnoea-index) | Sleep study parameters | at baseline and at least 8 weeks of CPAP as well as after 2 weeks of CPAP withdrawal | |
Secondary | Measures of OSA severity (oxygen-desaturation index) | Sleep study parameters | at baseline and at least 8 weeks of CPAP as well as after 2 weeks of CPAP withdrawal | |
Secondary | Sleepiness (Stanford Sleepiness Scale (SSS)) | Questionnaire; 7-point Likert scale to quantify a patient's sleepiness at the time the questionnaire is completed; highr scores indicate more sleepiness | at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal | |
Secondary | Fatigue (fatigue severity scale (FSS)) | Questionnaire; 9 items, higher score indicates more fatigue | at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal | |
Secondary | Disease-specific quality of life (Functional Outcomes of Sleep Questionnaire (FOSQ)) | Questionnaires, Disease-specific quality of life questionnaire to determine functional status in adults; measures are designed to assess the impact of disorders of excessive sleepiness on multiple activities of everyday living and the extent to which these abilities are improved by effective treatment; 30 items; higher scores are better | at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal | |
Secondary | Superoxide dismutase | Marker of oxidative stress (U/ml) | at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal | |
Secondary | Urinary catecholamines | Epinephrine and norepinephrine in morning urine (nnmol/mmol) | at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal | |
Secondary | Pulse rise index (>6 beats per minute) | from nocturnal oximetry | at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal | |
Secondary | Nocturnal oxymetry measures (¢SpO2, t<90, ODI-3%, ODI-4%) | nocturnal pulse oximetry | at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal |
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