Evaluation of Spa Treatment on Insomnia — SOMNOTHERM  

Insomnia Clinical Trial

Official title: Evaluation of Psychosomatic Spa Treatment With Crenotherapy to Potentiate the Implementation of Behavioral Measures for Insomnia Disorder Management

Status Recruiting

Clinical Trial Summary

Persistant insomnia is a common sleep disorder that affects approximately 20% of the French population. The standard treatment for chronic insomnia is Cognitive-Behavioral Therapy (CBT).

Behavioral measures can be difficult to implement for the patient alone at home.

Spa therapy with psychosomatic orientation allows to implement hygiene rules and structure rhythms of life. In addition, recent studies have shown that spa treatment, including crenotherapy, is effective in somatic complaints related to anxiety and benzodiazepine withdrawal.

The spa treatment could therefore provide ideal conditions for the implementation of behavioral measures for insomnia management.

The objective of SOMNOTHERM study is to measure efficiency on insomnia complaints at 8 weeks of a the implementation of a Behavioral therapy program for insomnia delivered by an internet software combined to a spa treatment compared to implementation of the same program at home (standard care).

Clinical Trial Description

Persistant insomnia is a common sleep disorder that affects approximately 20% of the French population.

The standard treatment for chronic insomnia is Cognitive-Behavioral Therapy (CBT). This therapy is based on 4 components: sleep restriction, stimulus control, cognitive therapy and sleep hygiene education. Unfortunately, there are an insufficient number of trained CBT experts especially in France.

Online programs based on CBT principles (e-CBT) have been proved to be effective in improving the sleep and daytime functioning in this population. Thus e-CBT can be an effective alternative to conventional CBT.

Behavioral measures, however, remains difficult for patients to implement alone at home.

Spa therapy with psychosomatic orientation allows to implement hygiene rules and structure rhythms of life. In addition, recent studies have shown that spa treatment, including crenotherapy, is effective in somatic complaints related to anxiety and benzodiazepine withdrawal.

In this context, spa treatment with psychosomatic orientation appears conducive to implement hygiene rules and structure rhythms of life. The spa treatment could therefore provide ideal conditions for the implementation of behavioral measures of insomnia management (sleep hygiene, stimulus control and time in bed restriction) and could have a very beneficial effect on persistent insomnia disorder.

This non-pharmacological therapy could also reduce hypnotics consumption (especially benzodiazepine).

The main hypothesis of the study is that behavioral measures of insomnia management delivered by an internet software program combined to a spa treatment will be more effective on insomnia complaints (evaluated at 8 weeks) than the same program implemented at home.

Patients will be followed during 6 months after the beginning of the program. Subjects' recruitment will be carried out from the list of patients registered for a spa treatment in one of the five spa centers participating in the study (Les Thermes de Saujon, Les Grands Thermes de Bagnères de Bigorre, Les Thermes de Divonne-les-Bains, Les thermes de Néris-les-Bains, Les Thermes d'Ussat-les-Bains).

Study visits will be conducted by the coordinating center (CHU Bordeaux) by telephone interviews or video calls with participants. ;

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

• NCT number: NCT03991247
• Study type: Interventional
• Source: Association Francaise pour la Recherche Thermale
• Contact: Jean-Arthur MICOULAUD-FRANCHI, MDPhD
• Phone: 557820173
• Email: jean-arthur.micoulaud-franchi@chu-bordeaux.fr
• Status: Recruiting
• Phase: N/A
• Start date: December 5, 2019
• Completion date: December 2023