SPA Therapy in the Treatment of Sleep Apnea Syndrome
- Conditions
- Obstructive Sleep Apnea SyndromeChronic Venous Insufficiency
- Interventions
- Other: 3-week immediate SPA treatmentOther: 3-week late SPA treatment
- Registration Number
- NCT02559427
- Lead Sponsor
- Association Francaise pour la Recherche Thermale
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Immediate SPA treatment 3-week immediate SPA treatment 3-week immediate SPA treatment (soon after randomization) Late SPA treatment 3-week late SPA treatment 3-week late SPA treatment (soon after primary endpoint at 4 1/2 months visit)
- Primary Outcome Measures
Name Time Method Apnea-Hypopnea Index (AHI) 4.5 months Variation in AHI according to the allocation group
- Secondary Outcome Measures
Name Time Method Specific Quality of life 4.5 months Variation in the scores of CIVIQ 20 according to the allocation group (Specific quality of life scale for venous insufficiency)
Global Quality of life 4.5 months Variation in the score of EUROQUOL according to the allocation group (Global quality of life scale)
Nocturnal hypoxemia 4.5 months Nocturnal hypoxemia is assessed by mean SpO2 and time spent with SpO2\<90%
Clinically significant improvement of OSAS 4.5 months 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
Quality of Sleep 4.5 months Quality of sleep is assessed by Quebec Quality of life Questionnaire
severity of sleep apnea 4.5 months 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
Sleep duration 4.5 months Mean sleep duration is assessed by actigraphy over a period of 7 days.
Daytime sleepiness 4.5 months Sleepiness is assessed by Epworth sleepiness scale
Variation of interstitial fluid 4.5 months bioimpedance is used to measure interstitial fluid
Venous insufficiency variation 1 year Variation of venous insufficiency is assessed by Villalta score
long term effect of the SPA treatment on primary outcome 1 year 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)
Long term efficacy 1 year Long term efficacy is measured by nocturnal respiratory polygraphy only in patients who are not treated by CPAP
long term effect of the SPA treatment on specific quality of life 1 year 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
long term effect of the SPA treatment on specific treatment of OSAS 1 year 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).
Venous insufficiency classification 1 year Variation of venous insufficiency is assessed by CEAP classification
Venous insufficiency examination 1 year Variation of venous insufficiency is assessed by leg circumferences
long term effect of the SPA treatment on global quality of life 1 year 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
long term effect of the SPA treatment on venous insufficiency 1 year 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
benefit for patients with first SPA treatment 4.5 months 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.
Trial Locations
- Locations (4)
University Hospital Grenoble
🇫🇷Grenoble, France
Medical pratice (angiology)
🇫🇷Tarbes, France
Medical practice (angiology)
🇫🇷Valence, France
Clinic Beau Soleil
🇫🇷Montpellier, France