NCT02559427

SPA Therapy in the Treatment of Sleep Apnea Syndrome

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Association Francaise pour la Recherche Thermale · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obstructive Sleep Apnea Syndrome
• Chronic Venous Insufficiency

Interventions

Type	Name	Description
OTHER	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...)
OTHER	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...)

Timeline

• Start date: 2016-10-01
• Primary completion: 2018-06-01
• Completion: 2019-03-01
• First posted: 2015-09-24
• Last updated: 2018-06-29

Locations

9 sites across 1 country: France