Clinical Trials Logo
  1. Home
  2. Obstructive Sleep Apnea Syndrome
  3. NCT01090297

Continuous Positive Airway Pressure (CPAP) Mode Impact on Clinical Blood Arterial Pressure — AgirSASadom  

Obstructive Sleep Apnea Syndrome Clinical Trial

Official title:
CPAP Treatment : Fixed Versus Auto-adjusting Mode Impact on Clinical Blood Arterial Pressure. Randomised, Controlled and Double Blinded Trial in SAOS Patients

Clinical Trial Summary

Background: Continuous positive airway pressure (CPAP) is the first line therapy for obstructive sleep apnea syndrome (OSAS). Two positive airway pressure (PAP) modalities can be used: Fixed pressure, in which the effective pressure is set and kept constant all night, and auto CPAP devices where the positive pressure changes during the night depend on patient's requirements.

Hypothesis: Pressure variations associated with autoCPAP functioning can lead to sleep fragmentation and alterations in sleep structure. This can limit blood pressure dipping during sleep and then impact clinical blood pressure reduction.

Main objective: To compare in a randomized controlled trial 4 months clinical blood pressure (BP) evolution depending on CPAP mode: fixed pressure versus autoCPAP. Secondary outcomes: Evolution of arterial stiffness, biological parameters, quality of life and symptoms.

Methods: Patients will be randomised depending on CPAP mode. Baseline and 4 months evaluation will include: 24-h ambulatory blood pressure monitoring, clinical BP measurements and carotid-to-femoral pulse wave velocity (PWV). Patients will also complete quality of life and symptoms questionnaires.

2 interim analysis will be carried out when 150 and 220 patients respectively will have completed the study. The Peto's method will be used to correct the p-values.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01090297
Study type Interventional
Source AGIR à Dom
Contact
Status Completed
Phase N/A
Start date September 2009
Completion date November 2012
View Details
See also
  Status Clinical Trial Phase
Withdrawn NCT05164211 - Didgeridoo Treatment to Improve Pharyngeal Compliance in Obstructive Sleep Apnea-hypopnea Syndrome in Children N/A
Active, not recruiting NCT05049928 - m-Rehab OSA : Impact of a Telerehabilitation Program Associated With CPAP on Severity Markers of Obstructive Sleep Apnea Syndrome N/A
Not yet recruiting NCT04538274 - Trained Patient Involvement to Promote the Resumption of CPAP in Patients Who Have Discontinued Its Use N/A
Completed NCT02967367 - Reliability of Consumer Sleep Trackers in Patients Suffering From Obstructive Sleep Apnea Syndrome N/A
Completed NCT02180672 - Steroids for Pediatric Apnea Research in Kids Phase 3
Recruiting NCT01561677 - Consequences of Obstructive Sleep Apnea Syndrome (OSAS) After Ischemic Subtentorial Stroke. N/A
Completed NCT01808508 - Obstructive Sleep Apnea and Neurocognitive and Cardiovascular Function in Children With Down Syndrome N/A
Completed NCT01193738 - Osteopathy and Obstructive Sleep Apnea Syndrome N/A
Completed NCT00850876 - Heated Humidified Continuous Positive Airway Pressure and Nasal Physiology N/A
Completed NCT00801671 - Russian Study of the Effect of Continuous Positive Airway Pressure (CPAP) in Hypertension Phase 3
Completed NCT02085720 - Prevalence of OSAS in Chinese Elderly and Its CPAP Compliance N/A
Recruiting NCT00874913 - Study of Ocular Blood Flow in Patients With Glaucoma and/or Obstructive Sleep Apnea Syndrome (OSAS) N/A
Completed NCT00156442 - A Study to Examine the Relationship Between Sleep Apnea and Cleft Lip/Palate N/A
Withdrawn NCT00156455 - Sleep Disordered Breathing in Children With Single Ventricle Physiology N/A
Completed NCT00222963 - Pilot Study to Assess the Effectiveness of Tonsil and Adenoidectomy (T+A) in Overweight Children and Adolescents N/A
Completed NCT01045499 - LAGB as a Treatment for Morbid Obesity in Adolescents N/A
Completed NCT02995837 - Cerebral Blood Flow and Childhood Obstructive Sleep Apnea
Withdrawn NCT02559427 - SPA Therapy in the Treatment of Sleep Apnea Syndrome N/A
Completed NCT02522819 - Feasibility Evaluation of CPAP in the Treatment of Obstructive Sleep Apnea Synchrone in the Acute Phase of Stroke N/A
Completed NCT01289405 - Phonoaudiologic Therapy Adjunct to Treatment on Patients With Obstructive Sleep Apnea N/A