Obstructive Sleep Apnea Clinical Trial
— STIFFSLEEPOfficial title:
Use of CPAP to Reduce Arterial Stiffness in Moderate to Severe Obstructive Sleep Apnea, Without Excessive Daytime Sleepiness (STIFFSLEEP)
Verified date | July 2017 |
Source | Centro Hospitalar de Lisboa Central |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study intends to determine whether continuous positive airway pressure (CPAP) can reduce arterial stiffness (measured by pulse wave velocity) in nonsleepy as well as in sleepy patients with obstructive sleep apnea .
Status | Terminated |
Enrollment | 45 |
Est. completion date | June 2017 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 30 Years to 65 Years |
Eligibility |
Inclusion Criteria: - moderate to severe obstructive sleep apnea, defined as apnea/hypopnea index superior to 15 Exclusion Criteria: - Epworth sleep scale superior to 16 - other sleep diseases - moderate or severe lung disease - cardiac disease other than hypertension - cerebrovascular diseases - other vascular diseases - other chronic diseases except metabolic syndrome |
Country | Name | City | State |
---|---|---|---|
Portugal | Consulta de Sono, Departamento de Pneumologia, Centro Hospitalar de Lisboa Central | Lisboa | |
Portugal | Núcleo de Hipertensão Arterial, Consulta de Medicina do Hospital de Santa Marta, Centro Hospitalar de Lisboa Central | Lisboa |
Lead Sponsor | Collaborator |
---|---|
Centro Hospitalar de Lisboa Central | Universidade Nova de Lisboa |
Portugal,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Lipidic profile | total serum cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides | Change from baseline up to three months of intervention | |
Other | Glucidic profile | fasting serum glucose and HbA1c | Change from baseline up to three months of intervention | |
Primary | Aortic pulse wave velocity (PWV) | carotid-femoral (aortic) pulse wave velocity (PWV) measured by noninvasive piezo-electronic system with Complior(R) (Colson, France). | Change on PWV from baseline up to three months of intervention | |
Secondary | Apnea-Hypopnea Index (AHI) | AHI is an index used to assess the severity of sleep apnea based on the total number of complete cessations (apnea) and partial obstructions (hypopnea) of breathing occurring per hour of sleep, using polygraphic study. | Change on AHI from baseline up to three months of intervention | |
Secondary | Nocturnal oxygenation | Measure of minimal saturation of oxygen (SO2), time under 90% SO2, average SO2, oxygen desaturation index, using polygraphic study. | Change from baseline up to three months of intervention | |
Secondary | Excessive daytime sleepiness | Epworth sleep scale (ESS) | Change on ESS from baseline up to three months of intervention |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05857384 -
Bioavailability, Bioequivalence and Tolerability of IHL-42X Compared to the Reference Drugs
|
Phase 1 | |
Recruiting |
NCT04547543 -
Follow-up of Apneic Patients by Visio-consultation
|
N/A | |
Recruiting |
NCT05371509 -
Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study
|
N/A | |
Completed |
NCT02515357 -
Mediterranean Diet/Lifestyle Intervention in Obstructive Sleep Apnea
|
N/A | |
Completed |
NCT05582070 -
Effect on Sleep of Surgical Treatment of Severe Nasal Obstruction
|
N/A | |
Active, not recruiting |
NCT03189173 -
Combined Upper-airway and Breathing Control Therapies for Obstructive Sleep Apnea
|
Phase 2 | |
Completed |
NCT04084899 -
The Effect of CPAP on Lung Hyperinflation in Patients With OSA
|
||
Completed |
NCT03032029 -
Registry on the Treatment of Central and Complex Sleep-Disordered Breathing With Adaptive Servo-Ventilation
|
||
Recruiting |
NCT04028011 -
Clinical Evaluation of a Wearable Technology for the Diagnosis of Sleep Apnoea
|
||
Recruiting |
NCT06047353 -
Community Health Advocates for Motivating PAP Use in Our Neighborhoods.
|
N/A | |
Completed |
NCT05253963 -
Acute Effect of CPAP on Weight in Patients With Obstructive Sleep Apnea
|
N/A | |
Recruiting |
NCT06029959 -
Stroke and CPAP Outcome Study 3
|
N/A | |
Recruiting |
NCT06150352 -
Sleep Apnea, Neurocognitive Decline and Brain Imaging in Patients With Subjective or Mild Cognitive Impairment
|
||
Completed |
NCT03589417 -
Postural Stability, Balance and Fall Risk in Patients With Obstructive Sleep Apnea
|
||
Recruiting |
NCT04335994 -
ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing
|
N/A | |
Withdrawn |
NCT04063436 -
Evaluation of a New Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea
|
N/A | |
Recruiting |
NCT05385302 -
Sociological Determinants of Positive Airway Pressure Adherence in OSA Patients
|
||
Recruiting |
NCT04572269 -
Metabolomics of Obstructive Sleep Apnea
|
||
Not yet recruiting |
NCT06467682 -
12-week Tele-exercise Program in Patients With OSA
|
N/A | |
Withdrawn |
NCT04011358 -
Retinal Vein Occlusion and Obstructive Sleep Apnea: A Case Control Study
|
N/A |