Effect of Compression Stockings on the Number of Apneas/Hypopneas Per Hour of Sleep in Patients With Syndrome Obstructive Sleep Apnea/Hypopnea as Compared to no Treatment

Last updated: May 2, 2026
Sponsor: Sigvaris France
Overall Status: Completed

Phase

N/A

Condition

Sleep Apnea Syndromes

Treatment

Wearing of specific compression stockings

Clinical Study ID

NCT05477719
2021-A00826-35
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • patient with moderate to severe sleep apnea-hypopnea syndrome confirmed bypolysomnography dating less than 3 months with an index of apneas/hypopneas ≥ 15apneas-hypopneas/h

  1. having been previously treated with nasal ventilation by continuous positiveairway pressure and mandibular orthosis and having stopped treatment for atleast 10 days, regardless of the duration of use of these two treatments

  2. or never treated for their sleep apnea-hypopnea syndrome satisfying thefollowing 3 criteria

  3. having 1 or 2 of the following signs daytime sleepiness, severe and dailysnoring, feelings of suffocation or suffocation during sleep, daytimefatigue, nocturia, morning headaches.

  4. absence of serious cardiovascular or respiratory comorbidity

  5. absence of severe daytime sleepiness and/or accidental risk that couldlead to direct or indirect bodily harm

  • stable weight (5% variation of the weight at the time of the polysomnography donewithin 3 months)

  • patient without varicose veins, without trophic disorder that could suggest moderateto severe superficial or deep venous insufficiency (dermatitis, hypodermatitis,active or healed ulcer)

  • sedentary patient (patient seated more than 8 h/d

Exclusion

Exclusion Criteria:

  • daily wearing of medical compression

  • patient with a contraindication to wearing a compression garment

  • patient unable to apply compression (preliminary test)

  • taking diuretics or venotonics

  • obesity (body mass index > 30 kg/m2)

  • patient with leg dermatosis

  • patient with leg or thigh muscle trauma less than three months old

  • patient with sciatica, cruralgia or acute low back pain

  • pregnant or post-pregnancy women less than 6 months old or of childbearing agewithout an effective method of contraception

  • heart, liver or kidney failure

  • lymphedema of the lower limbs

  • cancer not considered to be in remission

  • history of abdominal radiotherapy

Study Design

Total Participants: 25
Treatment Group(s): 1
Primary Treatment: Wearing of specific compression stockings
Phase:
Study Start date:
September 06, 2022
Estimated Completion Date:
March 13, 2024

Connect with a study center

  • Service des Pathologies du Sommeil Bâtiment EOLE GH Pitié-Salpêtrière

    Paris, 75013
    France

    Site Not Available

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