SPA Therapy in the Treatment of Sleep Apnea Syndrome

Study Overview
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Brief Summary
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The purpose of this study is to determine whether 3-week of SPA therapy improves sleep apnea in patients with chronic venous insufficiency and concomitant Obstructive Sleep Apnea Syndrome (OSAS).

Detailed Description
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Obstructive Sleep Apnea Syndrome (OSAS), characterized by repetitive episodes of partial or complete upper airway (UA) obstruction, is highly prevalent in the general population (2% in women, 4% in men). OSAS is associated with hypersomnolence and it increases the risk of cardiovascular morbidity and mortality. Its pathogenesis is largely multifactorial. In patients with chronic venous insufficiency, fluid retention contributes to this pathogenesis: during the day, fluid accumulates in the legs due to gravity ; during sleep in recumbent position, this accumulated fluid redistributes rostrally in the neck and causes upper airway narrowing and predisposes to OSAS. The hypothesis is that a comprehensive treatment program for chronic venous insufficiency (SPA therapy) would reduce sleep apnea in patients with chronic venous insufficiency and concomitant sleep apnea Syndrome. The objective is to assess the efficacy of a 3-week SPA therapy on attenuation of sleep apnea in this population of patients.

Official Title
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Impact of 3-week SPA Therapy on Sleep Apnea in Patients With Obstructive Sleep Apnea Syndrome and Chronic Venous Insufficiency: A Randomized, Controlled Study

Conditions
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Obstructive Sleep Apnea Syndrome, Chronic Venous Insufficiency

Intervention / Treatment
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* Other: 3-week immediate SPA treatment
* Other: 3-week late SPA treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with Chronic Venous Insufficiency with oedema (CEAP clinical classes C3 to C5) and concomitant Sleep Apnea Syndrome (AHI > 15 events/hour) Patient in stable state (no change in medical treatment and no hospitalization for respiratory, cardiac or metabolic event in the 2 months preceding inclusion) Patient available for a program of 3-week SPA Therapy Exclusion Criteria: Patient with no social insurance Pregnant and nursing woman Patient detained by judicial order Patient with contra-indication to SPA therapy Patient with chronic venous insufficiency < CEAP C3 or CEAP C6 Patient already treated by class IV compression stockings for severe veinolymphatic insufficiency Patient already treated for sleep apnea Patient who have already benefited of SPA therapy (any type) within 9 months before the enrollment Patient with severe comorbidities Patient who could not respect the constraints related to the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Immediate SPA treatment<br>3-week immediate SPA treatment (soon after randomization) | Other: 3-week immediate SPA treatment<br>* a comprehensive program soon after randomization including sessions of balneotherapy, diet information, exercise training. The most adapted to the concerned pathology and common to all SPA resorts (walk in a specially pool, whirlpool bath with automatic air and water massages cycles, massages shower...)<br>* Other names: Immediate SPA treatment;|
| Sham Comparator: Late SPA treatment<br>3-week late SPA treatment (soon after primary endpoint at 4 1/2 months visit) | Other: 3-week late SPA treatment<br>* a comprehensive program after 4.5 months, including sessions of balneotherapy, diet information, exercise training. The most adapted to the concerned pathology and common to all SPA resorts (walk in a specially pool, whirlpool bath with automatic air and water massages cycles, massages shower...)<br>* Other names: Late SPA treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea-Hypopnea Index (AHI) | Variation in AHI according to the allocation group | 4.5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specific Quality of life | Variation in the scores of CIVIQ 20 according to the allocation group (Specific quality of life scale for venous insufficiency) | 4.5 months | 
| Global Quality of life | Variation in the score of EUROQUOL according to the allocation group (Global quality of life scale) | 4.5 months | 
| severity of sleep apnea | Variation of AHI according to the severity of sleep apnea at inclusion. Moderate sleep apnea (AHI <30) vs Severe Sleep apnea (AHI >30) at inclusion | 4.5 months | 
| Nocturnal hypoxemia | Nocturnal hypoxemia is assessed by mean SpO2 and time spent with SpO2<90% | 4.5 months | 
| Clinically significant improvement of OSAS | Clinically significant improvement is defined with a reduction in AHI by 50% or more and a reduction in oxygen desaturation index by 50% or more | 4.5 months | 
| Sleep duration | Mean sleep duration is assessed by actigraphy over a period of 7 days. | 4.5 months | 
| Quality of Sleep | Quality of sleep is assessed by Quebec Quality of life Questionnaire | 4.5 months | 
| Daytime sleepiness | Sleepiness is assessed by Epworth sleepiness scale | 4.5 months | 
| Variation of interstitial fluid | bioimpedance is used to measure interstitial fluid | 4.5 months | 
| Long term efficacy | Long term efficacy is measured by nocturnal respiratory polygraphy only in patients who are not treated by CPAP | 1 year | 
| Venous insufficiency classification | Variation of venous insufficiency is assessed by CEAP classification | 1 year | 
| Venous insufficiency variation | Variation of venous insufficiency is assessed by Villalta score | 1 year | 
| Venous insufficiency examination | Variation of venous insufficiency is assessed by leg circumferences | 1 year | 
| long term effect of the SPA treatment on primary outcome | confirmation of the long term effect of the SPA treatment at 1 year for the control group. Primary outcome evolution between 4.5 months and 12 months (evolution of AHI) | 1 year | 
| long term effect of the SPA treatment on specific quality of life | confirmation of the long term effect of the SPA treatment at 1 year for the control group. Evolution between 4.5 months and 12 months of specific quality of life with CIVIQ 20 scale | 1 year | 
| long term effect of the SPA treatment on global quality of life | confirmation of the long term effect of the SPA treatment at 1 year for the control group. Evolution between 4.5 months and 12 months of global quality of life with EUROQUOL Scale | 1 year | 
| long term effect of the SPA treatment on venous insufficiency | confirmation of the long term effect of the SPA treatment at 1 year for the control group. Evolution between 4.5 months and 12 months of venous insufficiency | 1 year | 
| long term effect of the SPA treatment on specific treatment of OSAS | confirmation of the long term effect of the SPA treatment at 1 year for the control group. Evolution between 4.5 months and 12 months. The long term effect will be confirmed if patients did not require a specific treatment of OSAS (for example CPAP (Continuous Positive Airway Pressure). | 1 year | 
| benefit for patients with first SPA treatment | stratification at randomization (first SPA treatment or not) to evaluate a higher benefit (variation of Apnea-Hypopnea Index (AHI)) for patients with first SPA treatment. Comparison of patients with first SPA treatment or not on primary outcome according to the allocation group. | 4.5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep apnea, Venous Insufficiency, SPA treatment