SPA Therapy in the Treatment of Sleep Apnea Syndrome (THERMA-SAS)

Association Francaise pour la Recherche Thermale

Status

Withdrawn

Conditions

Obstructive Sleep Apnea Syndrome

Chronic Venous Insufficiency

Treatments

Other: 3-week immediate SPA treatment

Other: 3-week late SPA treatment

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02559427

THERMA SAS

Details and patient eligibility

About

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).

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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