Clinical Trials Logo

Clinical Trial Summary

Obstructive sleep apnea syndrome (OSA) is a pathology that affects 2 to 15% of the French adult population and more than 30% of subjects over 65 years old. It consists of repeated collapses of the upper airways during sleep leading to interruptions in ventilation (apneas) or significant reductions in ventilation (hypopneas). Balagny et al. have demonstrated the occurrence of hypertension in patients screened positive for sleep apnea syndrome in a French general population cohort. It is also established that sleep apnea increases the risk of cardiovascular disorders, such as metabolic syndrome (combining abdominal obesity and metabolic disorders), hypertension, heart rhythm disorders, especially at night, atherosclerosis (deposits of atheromatous plaques on the artery walls) or type 2 diabetes. These different complications increase the risk of cardiovascular accidents such as cardiac arrest, myocardial infarction, stroke, and expose to a risk of premature death (Inserm). The treatment of choice is night-time positive pressure ventilation, made possible by the use of a breathing apparatus (Continuous Positive Airway Pressure or CPAP). Alternatives to CPAP are the use of a nocturnal Mandibular Advancement Orthosis (MAO) which advances the jaw and allows a pharyngeal opening, and surgery in selected patients. The phenomenon at the origin of apneas is due to a relaxation of the muscles of the pharyngeal wall located at different heights. This obstruction is favored by anatomical particularities specific to each individual. The clinical examination can detect certain anomalies (enlarged tonsils, obstructive soft palate, prominent tongue base, abnormal epiglottis) and propose surgery to remove the obstruction. Nevertheless, it remains difficult to affirm that the detected anomaly is really at the origin of the obstruction and surgical failures are frequent. Endoscopy under induced sleep has been developed for about 10 years in France. This examination, widely used in the world, remains confidential in France. It consists, in the operating room, in inducing a medicated sleep (specific drugs delivered by an anesthetist) and performing a pharyngolaryngeal fibroscopy. The ENT physician can then visualize "live" the site and origin of the obstruction during an apnea. The main objective is to evaluate the interest of endoscopy under sleep before making a surgical indication in a patient presenting a sleep apnea syndrome. The secondary objective is to evaluate the reliability of sleep endoscopy.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05201222
Study type Observational
Source Groupe Hospitalier Paris Saint Joseph
Contact
Status Completed
Phase
Start date December 15, 2021
Completion date October 31, 2022

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 NCT01193738 - Osteopathy and Obstructive Sleep Apnea Syndrome N/A
Completed NCT01808508 - Obstructive Sleep Apnea and Neurocognitive and Cardiovascular Function in Children With Down Syndrome N/A
Completed NCT01090297 - Continuous Positive Airway Pressure (CPAP) Mode Impact on Clinical Blood Arterial Pressure 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
Completed NCT00222963 - Pilot Study to Assess the Effectiveness of Tonsil and Adenoidectomy (T+A) in Overweight Children and Adolescents N/A
Withdrawn NCT00156455 - Sleep Disordered Breathing in Children With Single Ventricle Physiology N/A
Completed NCT01045499 - LAGB as a Treatment for Morbid Obesity in Adolescents N/A
Withdrawn NCT02559427 - SPA Therapy in the Treatment of Sleep Apnea Syndrome N/A
Completed NCT02995837 - Cerebral Blood Flow and Childhood Obstructive Sleep Apnea
Completed NCT02522819 - Feasibility Evaluation of CPAP in the Treatment of Obstructive Sleep Apnea Synchrone in the Acute Phase of Stroke N/A