Study Results
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Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2016-10-31
2019-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Immediate SPA treatment
3-week immediate SPA treatment (soon after randomization)
3-week immediate 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...)
Late SPA treatment
3-week late SPA treatment (soon after primary endpoint at 4 1/2 months visit)
3-week late 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...)
Interventions
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3-week immediate 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...)
3-week late 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...)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Floralis
INDUSTRY
University Hospital, Grenoble
OTHER
Association Francaise pour la Recherche Thermale
OTHER
Responsible Party
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Principal Investigators
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Jean Louis PEPIN, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble
Locations
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Medical pratice (angiology)
Annecy, , France
Medical practice (angiology)
Bourgoin, , France
Medical practice (angiology)
Castelnau-le-Lez, , France
University Hospital Grenoble
Grenoble, , France
Medical pratice (angiology)
Grenoble, , France
University Hospital Grenoble
Grenoble, , France
Clinic Beau Soleil
Montpellier, , France
Medical pratice (angiology)
Tarbes, , France
Medical practice (angiology)
Valence, , France
Countries
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References
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Strollo PJ Jr, Soose RJ, Maurer JT, de Vries N, Cornelius J, Froymovich O, Hanson RD, Padhya TA, Steward DL, Gillespie MB, Woodson BT, Van de Heyning PH, Goetting MG, Vanderveken OM, Feldman N, Knaack L, Strohl KP; STAR Trial Group. Upper-airway stimulation for obstructive sleep apnea. N Engl J Med. 2014 Jan 9;370(2):139-49. doi: 10.1056/NEJMoa1308659.
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Other Identifiers
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THERMA SAS
Identifier Type: -
Identifier Source: org_study_id
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