Sleep Apnea SyndromesNCT05477719
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
A study testing Wearing of specific compression stockings in people with Sleep Apnea Syndromes, run by Sigvaris France at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea Syndromes
- What is being tested?
- Wearing of specific compression stockings
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 6 Sep 2022to 13 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Service des Pathologies du Sommeil Bâtiment EOLE GH Pitié-Salpêtrière
Paris, 75013
About this study
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
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.
Read more
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.
- Conditions
- Sleep Apnea Syndromes
- Being tested
- Wearing of specific compression stockings
- Keywords
- Obstructive sleep apnea, Fluid, Sedentary living, Compression stockings
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearing of specific compression stockingsDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Compression stockings - No Compression | Experimental | The patient will wear specific compression stockings in the first phase, and no compression in the second phase of the study Receives: Device: Wearing of specific compression stockings |
| No Compression - Compression stockings | Experimental | The patient won't wear anything in the first phase, and specific compression stockings in the second phase of the study Receives: Device: Wearing of specific compression stockings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the number of apneas/hypopneas
Measured: 28 days
Secondary outcomes (8)
Proportion of patients with a 50% reduction in the apnea-hypopnea index
Measured: 28 days
Proportion of patients with an apnea-hypopnea index < 30/hour
Measured: 28 days
Proportion of patients with an apnea-hypopnea index < 15/hour
Measured: 28 days
Proportion of patients with a 50% reduction in the apnea-hypopnea index and an apnea-hypopnea index < 15/hour
Measured: 28 days
Change in sleep habits and characteristics
Change in sleep habits and characteristics will be evaluated with an ad hoc questionnaire
Measured: 28 days
Change in sleepiness
Sleepiness will be assessed by Epworth scale
Measured: 28 days
Change in clinical signs of rostral displacement of fluids
Measured: 28 days
Tolerance overall judgment and questionnaire and adverse events)
overall judgment by the patient and questionnaire filled by the investigator
Measured: 28 days (only during the phase with the wearing of compression stockings
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start6 Sep 2022
- Primary completion13 Mar 2024
- Study completion13 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sigvaris France
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clin-Experts
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05477719
- Sponsor's protocol ID
- 2021-A00826-35
- Status last verified
- May 2026
- First submitted
- 26 Jul 2022
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05477719
- Acronym / sponsor ID
- 2021-A00826-35
- Conditions
- Sleep Apnea Syndromes
- Keywords
- Obstructive sleep apnea, Fluid, Sedentary living, Compression stockings
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Sigvaris FranceIndustry (pharma, biotech, devices)
- Collaborators
- Clin-Experts
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 13 Mar 2024 (actual)
- Study completion
- 13 Mar 2024 (actual)
- First posted
- 28 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Compression stockings - No Compression | Experimental | Device: Wearing of specific compression stockingsThe patient will wear specific compression stockings in the first phase, and no compression in the second phase of the study |
| No Compression - Compression stockings | Experimental | Device: Wearing of specific compression stockingsThe patient won't wear anything in the first phase, and specific compression stockings in the second phase of the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearing of specific compression stockingsThe 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 | Device | Compression stockings - No Compression, No Compression - Compression stockings |
Primary outcome
Change in the number of apneas/hypopneas
Time frame: 28 days
8 secondary outcomes
Proportion of patients with a 50% reduction in the apnea-hypopnea index
Time frame: 28 days
Proportion of patients with an apnea-hypopnea index < 30/hour
Time frame: 28 days
Proportion of patients with an apnea-hypopnea index < 15/hour
Time frame: 28 days
Proportion of patients with a 50% reduction in the apnea-hypopnea index and an apnea-hypopnea index < 15/hour
Time frame: 28 days
Change in sleep habits and characteristics
Time frame: 28 days
Change in sleepiness
Time frame: 28 days
Change in clinical signs of rostral displacement of fluids
Time frame: 28 days
Tolerance overall judgment and questionnaire and adverse events)
Time frame: 28 days (only during the phase with the wearing of compression stockings
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No
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Comprehensive Opioid Management and Breathing During Sleep
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A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearing of specific compression stockings in people with Sleep Apnea Syndromes, run by Sigvaris France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the number of apneas/hypopneas (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.