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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02559427
Other study ID # THERMA SAS
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date October 2016
Est. completion date March 2019

Study information

Verified date June 2018
Source Association Francaise pour la Recherche Thermale
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date March 2019
Est. primary completion date June 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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...)
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...)

Locations

Country Name City State
France Medical pratice (angiology) Annecy
France Medical practice (angiology) Bourgoin Jallieu
France Medical practice (angiology) Castelnau Le Lez
France Medical pratice (angiology) Grenoble
France University Hospital Grenoble Grenoble
France University Hospital Grenoble Grenoble
France Clinic Beau Soleil Montpellier
France Medical pratice (angiology) Tarbes
France Medical practice (angiology) Valence

Sponsors (3)

Lead Sponsor Collaborator
Association Francaise pour la Recherche Thermale Floralis, University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (34)

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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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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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. — View Citation

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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. — View Citation

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* Note: There are 34 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Apnea-Hypopnea Index (AHI) Variation in AHI according to the allocation group 4.5 months
Secondary Specific Quality of life Variation in the scores of CIVIQ 20 according to the allocation group (Specific quality of life scale for venous insufficiency) 4.5 months
Secondary Global Quality of life Variation in the score of EUROQUOL according to the allocation group (Global quality of life scale) 4.5 months
Secondary severity of sleep apnea 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 4.5 months
Secondary Nocturnal hypoxemia Nocturnal hypoxemia is assessed by mean SpO2 and time spent with SpO2<90% 4.5 months
Secondary Clinically significant improvement of OSAS 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 4.5 months
Secondary Sleep duration Mean sleep duration is assessed by actigraphy over a period of 7 days. 4.5 months
Secondary Quality of Sleep Quality of sleep is assessed by Quebec Quality of life Questionnaire 4.5 months
Secondary Daytime sleepiness Sleepiness is assessed by Epworth sleepiness scale 4.5 months
Secondary Variation of interstitial fluid bioimpedance is used to measure interstitial fluid 4.5 months
Secondary Long term efficacy Long term efficacy is measured by nocturnal respiratory polygraphy only in patients who are not treated by CPAP 1 year
Secondary Venous insufficiency classification Variation of venous insufficiency is assessed by CEAP classification 1 year
Secondary Venous insufficiency variation Variation of venous insufficiency is assessed by Villalta score 1 year
Secondary Venous insufficiency examination Variation of venous insufficiency is assessed by leg circumferences 1 year
Secondary long term effect of the SPA treatment on primary outcome 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) 1 year
Secondary long term effect of the SPA treatment on specific quality of life 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 1 year
Secondary long term effect of the SPA treatment on global quality of life 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 1 year
Secondary long term effect of the SPA treatment on venous insufficiency 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 1 year
Secondary long term effect of the SPA treatment on specific treatment of OSAS 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). 1 year
Secondary benefit for patients with first SPA treatment 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. 4.5 months
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