Evaluation of Spa Treatment on Insomnia
SOMNOTHERM
Evaluation of Psychosomatic Spa Treatment With Crenotherapy to Potentiate the Implementation of Behavioral Measures for Insomnia Disorder Management
2 other identifiers
interventional
178
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2019
CompletedFirst Posted
Study publicly available on registry
June 19, 2019
CompletedStudy Start
First participant enrolled
December 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedMay 31, 2022
May 1, 2022
4 years
June 17, 2019
May 25, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Insomnia Severity Scale (ISI) score
7-item questionnaire assessing insomnia nature, severity and impact. The global score ranges from 0 to 28.
Week 10 = 8 weeks after beginning of computerized behavioral therapy (starting of time in bed restriction)
Secondary Outcomes (21)
Total sleep time (TST) obtained by sleep diary
Every night between starting of sleep diary completion (Day 0) and Month 6 (study termination)
Sleep efficiency (SE) obtained by sleep diary
Every night between starting of sleep diary completion (Day 0) and Month 6 (study termination)
Sleep latency obtained by sleep diary
Every night between starting of sleep diary completion (Day 0) and Month 6 (study termination)
Insomnia Severity Scale (ISI) score
On Day 0, Week 5, Week 7, Month 4, Month 6
EQ-5-D
On Day 0, Week 5, Week 7, Week 10, Month 4, Month 6
- +16 more secondary outcomes
Study Arms (2)
Internet Behavioral therapy program + spa therapy
EXPERIMENTALPatient following a program of computerized behavioral therapy for insomnia management during a 3 weeks spa treatment.
Internet Behavioral therapy program at home
ACTIVE COMPARATORPatient following a program of computerized behavioral therapy for insomnia management during 3 weeks at home.
Interventions
The online program consists in restriction of time in bed and stimulus control instructions. First, patient will complete an on-line sleep diary during 2 weeks. The personalized program is then activated by a practitioner (phone interview) who both assesses restriction of time in bed and delivers instructions of stimulus control. Then, restriction of time in bed is administered by the internet-delivered self-help program. The participant still completes his on-line sleep diary every day. Every 7 days, according mean sleep efficiency, a new sleep schedule recommendation is given to the participant. In addition, the program delivers everyday a set of instructions (stimulus control) designed to re-associate the bed/bedroom with sleep and to re-establish a consistent sleep wake schedule. The duration of restriction of time in bed program is 3 weeks (during spa treatment or at home depending on the allocated arm).
Spa treatment is harmonized in the different stations. It consists in: * a medical thermal follow-up: weekly medical consultation of 15 minutes during the 3 weeks spa treatment. * an institutional follow-up: support, help and monitoring of patients during spa treatment * Crenotherapy: 18 baths of 10 minutes in running water, 18 spa showers of 3 minutes, 9 massages under water of 20 minutes, 18 baths of 10 minutes in pool. Water temperature of pool is between 31°C and 33°C. Water temperature for other care is 35°C and 38°C.
Eligibility Criteria
You may qualify if:
- Male or female aged between 18 and 80 years old
- Registered at one of the participating spas, for a psychosomatic spa treatment scheduled for the next 12 months, but within a period of more than 16 weeks.
- ISI score ≥ 8 on the pre-selection questionnaire
- Person with a persistent insomnia disorder, with or without comorbidities, according to DSM 5
- Owning or having access to a computer / tablet or smartphone and to an internet connection
- Affiliated to a national health service
- Having given written informed consent to participate in the trial.
You may not qualify if:
- Strong suspicion of obstructive sleep apnea (OSA) syndrome on the STOP-BANG questionnaire and restless legs syndrome on the RLS screening questionnaire
- Having started antidepressant treatment in the last 2 months or whose treatment dose has been increased in the last 2 months
- Having started treatment with anxiolytic, hypnotic or neuroleptic in the last month or whose dosage of treatment has been increased in the last month
- Having carried out a spa treatment in the last 6 months, whatever the specialty.
- Registered to follow a complementary program for insomnia disorders during the planned spa treatment
- Pregnant or lactating women
- Major under guardianship or curatorship
- Night and shift-workers
- Having undertaken trans-meridian travel (± 3H) in the previous 1 month
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Association Francaise pour la Recherche Thermalelead
- University Hospital, Bordeauxcollaborator
- University of Bordeauxcollaborator
Study Sites (1)
University Hospital, Bordeaux
Bordeaux, 33000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2019
First Posted
June 19, 2019
Study Start
December 5, 2019
Primary Completion
December 1, 2023
Study Completion
December 1, 2023
Last Updated
May 31, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share
Patient could request investigator or Data Protection Officer an access to IPD according to French regulation (act No. 78-17 of 6 January 1978 on data processing, data files and individual liberties, amended by act No. 2004-801 of 6 August 2004) and he EU General Data Protection Regulation (GDPR) of 27 april 2016 applicable since 25 May 2018.