THERMA-SAS: SPA Therapy in the Treatment of Sleep Apnea Syndrome
Study Details
Study Description
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).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Immediate SPA treatment 3-week immediate SPA treatment (soon after randomization) |
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 Names:
|
Sham Comparator: Late 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 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 Names:
|
Outcome Measures
Primary Outcome Measures
- Apnea-Hypopnea Index (AHI) [4.5 months]
Variation in AHI according to the allocation group
Secondary Outcome Measures
- Specific Quality of life [4.5 months]
Variation in the scores of CIVIQ 20 according to the allocation group (Specific quality of life scale for venous insufficiency)
- Global Quality of life [4.5 months]
Variation in the score of EUROQUOL according to the allocation group (Global quality of life scale)
- severity of sleep apnea [4.5 months]
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
- Nocturnal hypoxemia [4.5 months]
Nocturnal hypoxemia is assessed by mean SpO2 and time spent with SpO2<90%
- Clinically significant improvement of OSAS [4.5 months]
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
- Sleep duration [4.5 months]
Mean sleep duration is assessed by actigraphy over a period of 7 days.
- Quality of Sleep [4.5 months]
Quality of sleep is assessed by Quebec Quality of life Questionnaire
- Daytime sleepiness [4.5 months]
Sleepiness is assessed by Epworth sleepiness scale
- Variation of interstitial fluid [4.5 months]
bioimpedance is used to measure interstitial fluid
- Long term efficacy [1 year]
Long term efficacy is measured by nocturnal respiratory polygraphy only in patients who are not treated by CPAP
- Venous insufficiency classification [1 year]
Variation of venous insufficiency is assessed by CEAP classification
- Venous insufficiency variation [1 year]
Variation of venous insufficiency is assessed by Villalta score
- Venous insufficiency examination [1 year]
Variation of venous insufficiency is assessed by leg circumferences
- long term effect of the SPA treatment on primary outcome [1 year]
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)
- long term effect of the SPA treatment on specific quality of life [1 year]
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
- long term effect of the SPA treatment on global quality of life [1 year]
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
- long term effect of the SPA treatment on venous insufficiency [1 year]
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
- long term effect of the SPA treatment on specific treatment of OSAS [1 year]
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).
- benefit for patients with first SPA treatment [4.5 months]
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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Medical pratice (angiology) | Annecy | France | ||
2 | Medical practice (angiology) | Bourgoin Jallieu | France | ||
3 | Medical practice (angiology) | Castelnau Le Lez | France | ||
4 | University Hospital Grenoble | Grenoble | France | 38000 | |
5 | Medical pratice (angiology) | Grenoble | France | ||
6 | University Hospital Grenoble | Grenoble | France | ||
7 | Clinic Beau Soleil | Montpellier | France | ||
8 | Medical pratice (angiology) | Tarbes | France | ||
9 | Medical practice (angiology) | Valence | France |
Sponsors and Collaborators
- Association Francaise pour la Recherche Thermale
- Floralis
- University Hospital, Grenoble
Investigators
- Principal Investigator: Jean Louis PEPIN, MD, University Hospital, Grenoble
Study Documents (Full-Text)
None provided.More Information
Publications
- Caffo B, Diener-West M, Punjabi NM, Samet J. A novel approach to prediction of mild obstructive sleep disordered breathing in a population-based sample: the Sleep Heart Health Study. Sleep. 2010 Dec;33(12):1641-8.
- Chan AS, Sutherland K, Schwab RJ, Zeng B, Petocz P, Lee RW, Darendeliler MA, Cistulli PA. The effect of mandibular advancement on upper airway structure in obstructive sleep apnoea. Thorax. 2010 Aug;65(8):726-32. doi: 10.1136/thx.2009.131094.
- de Oliveira Rodrigues CJ, Marson O, Tufic S, Kohlmann O Jr, Guimarães SM, Togeiro P, Ribeiro AB, Tavares A. Relationship among end-stage renal disease, hypertension, and sleep apnea in nondiabetic dialysis patients. Am J Hypertens. 2005 Feb;18(2 Pt 1):152-7.
- Dempsey JA, Veasey SC, Morgan BJ, O'Donnell CP. Pathophysiology of sleep apnea. Physiol Rev. 2010 Jan;90(1):47-112. doi: 10.1152/physrev.00043.2008. Review. Erratum in: Physiol Rev.2010 Apr;90(2):797-8.
- Elias RM, Bradley TD, Kasai T, Motwani SS, Chan CT. Rostral overnight fluid shift in end-stage renal disease: relationship with obstructive sleep apnea. Nephrol Dial Transplant. 2012 Apr;27(4):1569-73. doi: 10.1093/ndt/gfr605. Epub 2011 Nov 5.
- Flemons WW, Reimer MA. Development of a disease-specific health-related quality of life questionnaire for sleep apnea. Am J Respir Crit Care Med. 1998 Aug;158(2):494-503.
- Forestier R, Desfour H, Tessier JM, Françon A, Foote AM, Genty C, Rolland C, Roques CF, Bosson JL. Spa therapy in the treatment of knee osteoarthritis: a large randomised multicentre trial. Ann Rheum Dis. 2010 Apr;69(4):660-5. doi: 10.1136/ard.2009.113209. Epub 2009 Sep 3.
- Friedman O, Bradley TD, Chan CT, Parkes R, Logan AG. Relationship between overnight rostral fluid shift and obstructive sleep apnea in drug-resistant hypertension. Hypertension. 2010 Dec;56(6):1077-82. doi: 10.1161/HYPERTENSIONAHA.110.154427. Epub 2010 Nov 8.
- Giles TL, Lasserson TJ, Smith BH, White J, Wright J, Cates CJ. Continuous positive airways pressure for obstructive sleep apnoea in adults. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD001106. Review.
- Gottlieb DJ, Yenokyan G, Newman AB, O'Connor GT, Punjabi NM, Quan SF, Redline S, Resnick HE, Tong EK, Diener-West M, Shahar E. Prospective study of obstructive sleep apnea and incident coronary heart disease and heart failure: the sleep heart health study. Circulation. 2010 Jul 27;122(4):352-60. doi: 10.1161/CIRCULATIONAHA.109.901801. Epub 2010 Jul 12.
- Haentjens P, Van Meerhaeghe A, Moscariello A, De Weerdt S, Poppe K, Dupont A, Velkeniers B. The impact of continuous positive airway pressure on blood pressure in patients with obstructive sleep apnea syndrome: evidence from a meta-analysis of placebo-controlled randomized trials. Arch Intern Med. 2007 Apr 23;167(8):757-64.
- Javaheri S. Sleep disorders in systolic heart failure: a prospective study of 100 male patients. The final report. Int J Cardiol. 2006 Jan 4;106(1):21-8.
- Kahn SR, Partsch H, Vedantham S, Prandoni P, Kearon C; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of post-thrombotic syndrome of the leg for use in clinical investigations: a recommendation for standardization. J Thromb Haemost. 2009 May;7(5):879-83. doi: 10.1111/j.1538-7836.2009.03294.x. Epub 2009 Jan 19.
- Kline CE, Crowley EP, Ewing GB, Burch JB, Blair SN, Durstine JL, Davis JM, Youngstedt SD. The effect of exercise training on obstructive sleep apnea and sleep quality: a randomized controlled trial. Sleep. 2011 Dec 1;34(12):1631-40. doi: 10.5665/sleep.1422.
- Lévy P, Pépin JL, Dematteis M. Pharyngeal neuropathy in obstructive sleep apnea: where are we going? Am J Respir Crit Care Med. 2012 Feb 1;185(3):241-3. doi: 10.1164/rccm.201111-1992ED.
- Logan AG, Perlikowski SM, Mente A, Tisler A, Tkacova R, Niroumand M, Leung RS, Bradley TD. High prevalence of unrecognized sleep apnoea in drug-resistant hypertension. J Hypertens. 2001 Dec;19(12):2271-7.
- Marin JM, Agusti A, Villar I, Forner M, Nieto D, Carrizo SJ, Barbé F, Vicente E, Wei Y, Nieto FJ, Jelic S. Association between treated and untreated obstructive sleep apnea and risk of hypertension. JAMA. 2012 May 23;307(20):2169-76. doi: 10.1001/jama.2012.3418.
- Marin JM, Carrizo SJ, Vicente E, Agusti AG. Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study. Lancet. 2005 Mar 19-25;365(9464):1046-53.
- Mirrakhimov AE. Physical exercise related improvement in obstructive sleep apnea. Look for the rostral fluid shift. Med Hypotheses. 2013 Feb;80(2):125-8. doi: 10.1016/j.mehy.2012.11.007. Epub 2012 Dec 3.
- Monahan K, Storfer-Isser A, Mehra R, Shahar E, Mittleman M, Rottman J, Punjabi N, Sanders M, Quan SF, Resnick H, Redline S. Triggering of nocturnal arrhythmias by sleep-disordered breathing events. J Am Coll Cardiol. 2009 Nov 3;54(19):1797-804. doi: 10.1016/j.jacc.2009.06.038.
- Papandreou C, Schiza SE, Bouloukaki I, Hatzis CM, Kafatos AG, Siafakas NM, Tzanakis NE. Effect of Mediterranean diet versus prudent diet combined with physical activity on OSAS: a randomised trial. Eur Respir J. 2012 Jun;39(6):1398-404. doi: 10.1183/09031936.00103411. Epub 2011 Oct 27.
- Peppard PE, Young T, Palta M, Skatrud J. Prospective study of the association between sleep-disordered breathing and hypertension. N Engl J Med. 2000 May 11;342(19):1378-84.
- Punjabi NM. The epidemiology of adult obstructive sleep apnea. Proc Am Thorac Soc. 2008 Feb 15;5(2):136-43. doi: 10.1513/pats.200709-155MG. Review.
- Rapoport DM, Garay SM, Epstein H, Goldring RM. Hypercapnia in the obstructive sleep apnea syndrome. A reevaluation of the "Pickwickian syndrome". Chest. 1986 May;89(5):627-35.
- Redolfi S, Arnulf I, Pottier M, Lajou J, Koskas I, Bradley TD, Similowski T. Attenuation of obstructive sleep apnea by compression stockings in subjects with venous insufficiency. Am J Respir Crit Care Med. 2011 Nov 1;184(9):1062-6. doi: 10.1164/rccm.201102-0350OC.
- Sharma SK, Agrawal S, Damodaran D, Sreenivas V, Kadhiravan T, Lakshmy R, Jagia P, Kumar A. CPAP for the metabolic syndrome in patients with obstructive sleep apnea. N Engl J Med. 2011 Dec 15;365(24):2277-86. doi: 10.1056/NEJMoa1103944. Retraction in: Sharma SK, Agrawal S, Damodaran D, Sreenivas V, Kadhiravan T, Lakshmy R, Jagia P, Kumar A. N Engl J Med. 2013 Oct 31;369(18):1770.
- 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.
- Sullivan CE, Issa FG, Berthon-Jones M, Eves L. Reversal of obstructive sleep apnoea by continuous positive airway pressure applied through the nares. Lancet. 1981 Apr 18;1(8225):862-5.
- Terán-Santos J, Jiménez-Gómez A, Cordero-Guevara J. The association between sleep apnea and the risk of traffic accidents. Cooperative Group Burgos-Santander. N Engl J Med. 1999 Mar 18;340(11):847-51.
- Vickers AJ, Altman DG. Statistics notes: Analysing controlled trials with baseline and follow up measurements. BMJ. 2001 Nov 10;323(7321):1123-4. Review.
- Yaggi HK, Concato J, Kernan WN, Lichtman JH, Brass LM, Mohsenin V. Obstructive sleep apnea as a risk factor for stroke and death. N Engl J Med. 2005 Nov 10;353(19):2034-41.
- Young T, Palta M, Dempsey J, Peppard PE, Nieto FJ, Hla KM. Burden of sleep apnea: rationale, design, and major findings of the Wisconsin Sleep Cohort study. WMJ. 2009 Aug;108(5):246-9.
- Yumino D, Redolfi S, Ruttanaumpawan P, Su MC, Smith S, Newton GE, Mak S, Bradley TD. Nocturnal rostral fluid shift: a unifying concept for the pathogenesis of obstructive and central sleep apnea in men with heart failure. Circulation. 2010 Apr 13;121(14):1598-605. doi: 10.1161/CIRCULATIONAHA.109.902452. Epub 2010 Mar 29.
- Yumino D, Wang H, Floras JS, Newton GE, Mak S, Ruttanaumpawan P, Parker JD, Bradley TD. Prevalence and physiological predictors of sleep apnea in patients with heart failure and systolic dysfunction. J Card Fail. 2009 May;15(4):279-85. doi: 10.1016/j.cardfail.2008.11.015. Epub 2009 Jan 21.
- THERMA SAS