Service des Pathologies du Sommeil Bâtiment EOLE GH Pitié-Salpêtrière
Paris, 75013, France
NCT Number: NCT05477719
The sleep apnea-hypopnea syndrome is characterized by the occurrence, during sleep, of abnormally frequent episodes of interruption of ventilation (apnea), or significant reduction in ventilation (hypopnea).
The main symptoms of sleep apnea-hypopnea syndrome are daytime sleepiness (caused by the fragmentation and breakdown of sleep) and nocturnal snoring; possibly accompanied by the following symptoms: non-restorative sleep, difficulty concentrating, nocturia, cognitive disorders, libido disorders.
The consequences of sleep apnea-hypopnea syndrome are multiple for the patient both in the short term and in the long term.
The short-term manifestations are as follows: daytime sleepiness, reduced alertness, difficulty driving (risk of road accidents), difficulty performing tasks (risk of accidents at work), memory and concentration problems , learning difficulties (especially in children), mood disorders. In the end, there is an alteration in the quality of life of the patient.
Sleep apnea-hypopnea syndrome also has long-term consequences: a link between sleep apnea-hypopnea syndrome and cardiovascular morbidity and mortality has been explored by several cohort studies.
Nasal ventilation by continuous positive airway pressure is considered the reference treatment for sleep apnea-hypopnea syndrome. The use of nasal ventilation by continuous positive airway pressure, compared to no treatment, is not associated with a reduced risk of cardiovascular outcomes or death in patients with sleep apnea according to a recent meta-analysis.
Mandibular advancement devices are an alternative treatment for nasal ventilation by continuous positive airway pressure. The acceptability of its treatments, whether nasal ventilation by continuous positive airway pressure or mandibular advancement devices, is not very good and some patients do not start treatment or abandon it because of the constraints related to these treatments. There is therefore a need to find other treatments.
The overnight rostral fluid displacement from the legs, related to prolonged sitting can generate edema in the neck, more precisely in the upper airways, and therefore obstructive respiratory dysfunctions responsible for sleep apnea-hypopnea syndrome. Correlations between nocturnal fluid shifts and the number of apneas/hypopneas have been demonstrated Previous studies has shown a reduction in the apnea-hypopnea index by the daytime preventive wearing of medical compression, which can reduce the extent of leg edema and the displacement of nocturnal fluids.
The aim of the present study is to show that daytime wearing of medical compression developed specifically to optimize its effect in this indication for 28 days versus not wearing it reduces the number of apneas/hypopneas in patients with sleep apnea-hypopnea syndrome.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Paris, 75013, France
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The patient will wear specific compression stockings prevent the accumulation of fluids during the day in the lower part of the body and thus limiting the nocturnal drainage effect from the lower part of the body to the upper part of the body
Time frame: 28 days
Time frame: 28 days
Time frame: 28 days
Time frame: 28 days
Time frame: 28 days
Time frame: 28 days
Change in sleep habits and characteristics will be evaluated with an ad hoc questionnaire
Time frame: 28 days
Sleepiness will be assessed by Epworth scale
Time frame: 28 days
Time frame: 28 days (only during the phase with the wearing of compression stockings
overall judgment by the patient and questionnaire filled by the investigator
Sigvaris France
Industry
Study Evaluating the Effect of Compression Stockings at Constant Pressure for 28 Days on the Number of Apneas/Hypopneas Per Hour of Sleep (Index of Apneas/Hypopneas) in Patients With Syndrome Obstructive Sleep Apnea/Hypopnea as Compared to no Treatment
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