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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

Primary Purpose

Sleep Apnea Syndromes

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Wearing of specific compression stockings
Sponsored by
Sigvaris France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sleep Apnea Syndromes focused on measuring Obstructive sleep apnea, Fluid, Sedentary living, Compression stockings

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

    1. having been previously treated with nasal ventilation by continuous positive airway pressure and mandibular orthosis and having stopped treatment for at least 10 days, regardless of the duration of use of these two treatments
    2. or never treated for their sleep apnea-hypopnea syndrome satisfying the following 3 criteria

      1. having 1 or 2 of the following signs daytime sleepiness, severe and daily snoring, feelings of suffocation or suffocation during sleep, daytime fatigue, nocturia, morning headaches.
      2. absence of serious cardiovascular or respiratory comorbidity
      3. absence of severe daytime sleepiness and/or accidental risk that could lead to direct or indirect bodily harm
  • stable weight (5% variation of the weight at the time of the polysomnography done within 3 months)
  • patient without varicose veins, without trophic disorder that could suggest moderate to severe superficial or deep venous insufficiency (dermatitis, hypodermatitis, active or healed ulcer)
  • sedentary patient (patient seated more than 8 h/d

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 age without 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Compression stockings - No Compression

No Compression - Compression stockings

Arm Description

The patient will wear specific compression stockings in the first phase, and no compression in the second phase of the study

The patient won't wear anything in the first phase, and specific compression stockings in the second phase of the study

Outcomes

Primary Outcome Measures

Change in the number of apneas/hypopneas

Secondary Outcome Measures

Proportion of patients with a 50% reduction in the apnea-hypopnea index
Proportion of patients with an apnea-hypopnea index < 30/hour
Proportion of patients with an apnea-hypopnea index < 15/hour
Proportion of patients with a 50% reduction in the apnea-hypopnea index and an apnea-hypopnea index < 15/hour
Change in sleep habits and characteristics
Change in sleep habits and characteristics will be evaluated with an ad hoc questionnaire
Change in sleepiness
Sleepiness will be assessed by Epworth scale
Change in clinical signs of rostral displacement of fluids
Tolerance overall judgment and questionnaire and adverse events)
overall judgment by the patient and questionnaire filled by the investigator

Full Information

First Posted
July 26, 2022
Last Updated
October 16, 2022
Sponsor
Sigvaris France
Collaborators
Clin-Experts
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1. Study Identification

Unique Protocol Identification Number
NCT05477719
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 6, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sigvaris France
Collaborators
Clin-Experts

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndromes
Keywords
Obstructive sleep apnea, Fluid, Sedentary living, Compression stockings

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Compression stockings - No Compression
Arm Type
Experimental
Arm Description
The patient will wear specific compression stockings in the first phase, and no compression in the second phase of the study
Arm Title
No Compression - Compression stockings
Arm Type
Experimental
Arm Description
The patient won't wear anything in the first phase, and specific compression stockings in the second phase of the study
Intervention Type
Device
Intervention Name(s)
Wearing of specific compression stockings
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in the number of apneas/hypopneas
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Proportion of patients with a 50% reduction in the apnea-hypopnea index
Time Frame
28 days
Title
Proportion of patients with an apnea-hypopnea index < 30/hour
Time Frame
28 days
Title
Proportion of patients with an apnea-hypopnea index < 15/hour
Time Frame
28 days
Title
Proportion of patients with a 50% reduction in the apnea-hypopnea index and an apnea-hypopnea index < 15/hour
Time Frame
28 days
Title
Change in sleep habits and characteristics
Description
Change in sleep habits and characteristics will be evaluated with an ad hoc questionnaire
Time Frame
28 days
Title
Change in sleepiness
Description
Sleepiness will be assessed by Epworth scale
Time Frame
28 days
Title
Change in clinical signs of rostral displacement of fluids
Time Frame
28 days
Title
Tolerance overall judgment and questionnaire and adverse events)
Description
overall judgment by the patient and questionnaire filled by the investigator
Time Frame
28 days (only during the phase with the wearing of compression stockings

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: patient with moderate to severe sleep apnea-hypopnea syndrome confirmed by polysomnography dating less than 3 months with an index of apneas/hypopneas ≥ 15 apneas-hypopneas/h having been previously treated with nasal ventilation by continuous positive airway pressure and mandibular orthosis and having stopped treatment for at least 10 days, regardless of the duration of use of these two treatments or never treated for their sleep apnea-hypopnea syndrome satisfying the following 3 criteria having 1 or 2 of the following signs daytime sleepiness, severe and daily snoring, feelings of suffocation or suffocation during sleep, daytime fatigue, nocturia, morning headaches. absence of serious cardiovascular or respiratory comorbidity absence of severe daytime sleepiness and/or accidental risk that could lead to direct or indirect bodily harm stable weight (5% variation of the weight at the time of the polysomnography done within 3 months) patient without varicose veins, without trophic disorder that could suggest moderate to severe superficial or deep venous insufficiency (dermatitis, hypodermatitis, active or healed ulcer) sedentary patient (patient seated more than 8 h/d 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 age without 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
Facility Information:
Facility Name
Service des Pathologies du Sommeil Bâtiment EOLE GH Pitié-Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphane ATTARD
Email
stephane.attard@aphp.fr
First Name & Middle Initial & Last Name & Degree
Maxime PATOUT, Dr
First Name & Middle Initial & Last Name & Degree
Cécile LONDNER, Dr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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