An interventional study of 3-week immediate SPA treatment and 3-week late SPA treatment in Obstructive Sleep Apnea Syndrome and Chronic Venous Insufficiency, sponsored by Association Francaise pour la Recherche Thermale. Withdrawn at 9 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-29.
Sponsored by Association Francaise pour la Recherche Thermale · Not applicable, Interventional, and Treatment
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).
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.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
Browse Apnea studies →Association Francaise pour la Recherche Thermale is the lead sponsor of 17 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
3-week immediate SPA treatment (soon after randomization)
Other: 3-week immediate SPA treatment
3-week late SPA treatment (soon after primary endpoint at 4 1/2 months visit)
Other: 3-week late SPA treatment
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...)
Also known as: Immediate SPA treatment
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...)
Also known as: Late SPA treatment
Apnea-Hypopnea Index (AHI)
Variation in AHI according to the allocation group
Time frame: 4.5 months
Specific Quality of life
Variation in the scores of CIVIQ 20 according to the allocation group (Specific quality of life scale for venous insufficiency)
Time frame: 4.5 months
Global Quality of life
Variation in the score of EUROQUOL according to the allocation group (Global quality of life scale)
Time frame: 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
Time frame: 4.5 months
Nocturnal hypoxemia
Nocturnal hypoxemia is assessed by mean SpO2 and time spent with SpO2\<90%
Time frame: 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
Time frame: 4.5 months
Sleep duration
Mean sleep duration is assessed by actigraphy over a period of 7 days.
Time frame: 4.5 months
Quality of Sleep
Quality of sleep is assessed by Quebec Quality of life Questionnaire
Time frame: 4.5 months
Daytime sleepiness
Sleepiness is assessed by Epworth sleepiness scale
Time frame: 4.5 months
Variation of interstitial fluid
bioimpedance is used to measure interstitial fluid
Time frame: 4.5 months
Long term efficacy
Long term efficacy is measured by nocturnal respiratory polygraphy only in patients who are not treated by CPAP
Time frame: 1 year
Venous insufficiency classification
Variation of venous insufficiency is assessed by CEAP classification
Time frame: 1 year
Venous insufficiency variation
Variation of venous insufficiency is assessed by Villalta score
Time frame: 1 year
Venous insufficiency examination
Variation of venous insufficiency is assessed by leg circumferences
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 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.
Time frame: 4.5 months
This study is withdrawn, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Association Francaise pour la Recherche Thermale