SPA Therapy in the Treatment of Sleep Apnea Syndrome

Obstructive Sleep Apnea Syndrome Clinical Trial

— THERMA-SAS  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02559427
• Other study ID #: THERMA SAS
• Status: Withdrawn
• Phase: N/A
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• Apnea
• Chronic Venous Insufficiency
• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome
• Venous Insufficiency

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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* Note: There are 34 references in all — Click 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