Ignite Creation Date:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-04-13 @ 5:40 PM
Study NCT ID:
NCT02559427
Status:
WITHDRAWN
Last Update Posted:
2018-06-29
First Post:
2015-07-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SPA Therapy in the Treatment of Sleep Apnea Syndrome
Sponsor:
Association Francaise pour la Recherche Thermale
Organization:
Study Overview
Official Title:
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WITHDRAWN
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
no patients randomized after more than one year sponsor decided to withdrawn the study.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
THERMA-SAS
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: