InsomniaSOMNOTHERMNCT03991247
Evaluation of Spa Treatment on Insomnia
A study testing Computerized behavioral therapy program delivered by internet for insomnia management and Spa treatment in people with Insomnia, run by Association Francaise pour la Recherche Thermale at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Insomnia
- What is being tested?
- Computerized behavioral therapy program delivered by internet for insomnia management and Spa treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteFrance
- Study dates
- 5 Dec 2019to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Major under guardianship or curatorship
- Night and shift-workers
- Having undertaken trans-meridian travel (± 3H) in the previous 1 month
Trial locations and contacts
1 site in 1 country.
Jean-Arthur MICOULAUD-FRANCHI, MDPhD contact
France1 site, 1 recruiting
- Recruiting
University Hospital, Bordeaux
Bordeaux, 33000
Jean-Arthur MICOULAUD-FRANCHI, MDPhD, 557820173 ext. +33, jean-arthur.micoulaud-franchi@chu-bordeaux.fr
Cécile KLOCHENDLER, 557821159 ext. +33, cecile.klochendler@chu-bordeaux.fr
About this study
Official title: Evaluation of Psychosomatic Spa Treatment With Crenotherapy to Potentiate the Implementation of Behavioral Measures for Insomnia Disorder Management
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.
Read more
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).
Read the detailed 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.
- Conditions
- Insomnia
- Being tested
- Computerized behavioral therapy program delivered by internet for insomnia management, Spa treatment
- Keywords
- Spa treatment, Cognitive Behavioral Therapy, Internet delivered self-help program, Insomnia, Sleep restriction, stimulus control, crenotherapy
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized behavioral therapy program delivered by internet for insomnia managementBehavioural
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 treatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Internet Behavioral therapy program + spa therapy | Experimental | Patient following a program of computerized behavioral therapy for insomnia management during a 3 weeks spa treatment. Receives: Behavioral: Computerized behavioral therapy program delivered by internet for insomnia management; Other: Spa treatment |
| Internet Behavioral therapy program at home | Active comparator | Patient following a program of computerized behavioral therapy for insomnia management during 3 weeks at home. Receives: Behavioral: Computerized behavioral therapy program delivered by internet for insomnia management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Scale (ISI) score
7-item questionnaire assessing insomnia nature, severity and impact. The global score ranges from 0 to 28.
Measured: 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
Total sleep time = total sleep episode minus awake time. Subject records in his online sleep diary bedtime, wake-up time, time asleep, intra-night awakenings.
Measured: Every night between starting of sleep diary completion (Day 0) and Month 6 (study termination)
Sleep efficiency (SE) obtained by sleep diary
Ratio of total sleep time (TST) to time in bed (TIB) (multiplied by 100 to yield a percentage).
Subject records in his online sleep diary bedtime, wake-up time, time asleep, intra-night awakenings.
Measured: Every night between starting of sleep diary completion (Day 0) and Month 6 (study termination)
Sleep latency obtained by sleep diary
Length of time to accomplish the transition from full wakefulness to sleep. Subject records in his online sleep diary bedtime, wake-up time, time asleep, intra-night awakenings.
Measured: Every night between starting of sleep diary completion (Day 0) and Month 6 (study termination)
Insomnia Severity Scale (ISI) score
7-item questionnaire that assesses insomnia nature, severity and impact.
Measured: On Day 0, Week 5, Week 7, Month 4, Month 6
EQ-5-D
Standardized instrument for measuring generic health status.
Measured: On Day 0, Week 5, Week 7, Week 10, Month 4, Month 6
The Presleep State Arousal Scale (PSAS)
16-item questionnaire assessing whether the respondent experienced somatic (8 items, eg heart rate) or cognitive hyperarousal (eg racing thoughts) at bedtime
Measured: On Day 0, Week 5, Week 7, Week 10, Month 4, Month 6
Hospital Anxiety and Depression Scale (HAD)
14-item scale that generates ordinal data. Seven of the items relate to anxiety and seven relate to depression.
Measured: On Day 0, Week 5, Week 7, Week 10, Month 4, Month 6
Short Version of the Functional Outcomes of Sleep Questionnaire (FOSQ)
10 item questionnaire assessing the impact of excessive sleepiness on activities of daily living
Measured: On Day 0, Week 5, Week 7, Week 10, Month 4, Month 6
Rate of discontinuation and rate of reduction of anxiolytic hypnotic drugs and hypnotics
Every day anxiolytic hypnotic drugs and hypnotics daily dose
Measured: On Day 0, Week 5, Week 7, Week 10, Month 4, Month 6
Acceptability E-scale (AES)
6-item self-reported questionnaire that evaluates the extent to which patients find E-health systems acceptable
Measured: On week 10 (after computerized behavioral therapy program)
Client Satisfaction Questionnaire (CSQ-8)
8-item questionnaire easily scored and administered measurement that is designed to measure client satisfaction with services.
Measured: On week 10 (after computerized behavioral therapy program)
Sleep Condition Indicator (SCI)
brief 8-item scale which measures sleep problems against the DSM-5 criteria for insomnia disorder
Measured: On Day 0
The Pittsburgh Sleep Quality Index (PSQI)
self-report questionnaire that assesses sleep quality over a 1-month time interval
Measured: On Day 0
Cognitive Scale of Attachment to Benzodiazepines ("Echelle cognitive d'attachement aux benzodiazépines" ECAB)
10-item scale assessing cognitive component of attachment to benzodiazepines
Measured: On Day 0
The Munich ChronoType Questionnaire (MCTQ)
Questionnaire to determine Chrono Type.
Measured: On Day 0
The Epworth Sleepiness Scale (ESS)
8-item questionnaire assessing daytime sleepiness
Measured: On Day 0
Freiburg Mindfulness Inventory - short version (FMI)
questionnaire for measuring mindfulness
Measured: On Day 0
Krueger's personality inventory for DSM-5 in its brief form (PID-5-BF)
25-item self-report questionnaire assessing the presence and severity of the five maladaptive personality traits outlined in DSM-5.
Measured: On Day 0
The Arousal Predisposition Scale (APS)
12-item questionnaire assessing whether the respondent considers her/himself a stressful and emotionally reactive person
Measured: On Day 0
The Ford Insomnia to Stress Scale (FIRST)
9-item questionnaire assessing whether past and future stressful events are likely to affect sleep quality
Measured: On Day 0
The "locus of control for technology"-questionnaire ("Kontrollüberzeugungen im Umgang mit Technik" - KUT)
8-item questionnaire assessing the specific interaction with technical environments of users
Measured: On Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start5 Dec 2019
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association Francaise pour la Recherche Thermale
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Bordeaux, University of Bordeaux
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03991247
- Sponsor's protocol ID
- C2018-01
- Other IDs
- 2019-A00043-54
- Acronym
- SOMNOTHERM
- Status last verified
- May 2022
- First submitted
- 17 Jun 2019
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Psychosomatic Spa Treatment With Crenotherapy to Potentiate the Implementation of Behavioral Measures for Insomnia Disorder Management
- ClinicalTrials.gov ID
- NCT03991247
- Acronym / sponsor ID
- SOMNOTHERM / C2018-01
- Conditions
- Insomnia
- Keywords
- Spa treatment, Cognitive Behavioral Therapy, Internet delivered self-help program, Insomnia, Sleep restriction, stimulus control, crenotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Association Francaise pour la Recherche ThermaleUniversity, hospital or other
- Collaborators
- University Hospital, Bordeaux, University of Bordeaux
- Study start
- 5 Dec 2019 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 19 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet Behavioral therapy program + spa therapy | Experimental | Behavioral: Computerized behavioral therapy program delivered by internet for insomnia management, Other: Spa treatmentPatient following a program of computerized behavioral therapy for insomnia management during a 3 weeks spa treatment. |
| Internet Behavioral therapy program at home | Active comparator | Behavioral: Computerized behavioral therapy program delivered by internet for insomnia managementPatient following a program of computerized behavioral therapy for insomnia management during 3 weeks at home. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computerized behavioral therapy program delivered by internet for insomnia managementThe 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). | Behavioural | Internet Behavioral therapy program + spa therapy, Internet Behavioral therapy program at home |
| Spa treatmentSpa 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. | Other | Internet Behavioral therapy program + spa therapy |
Primary outcome
Insomnia Severity Scale (ISI) score
Time frame: Week 10 = 8 weeks after beginning of computerized behavioral therapy (starting of time in bed restriction)
7-item questionnaire assessing insomnia nature, severity and impact. The global score ranges from 0 to 28.
21 secondary outcomes
Total sleep time (TST) obtained by sleep diary
Time frame: Every night between starting of sleep diary completion (Day 0) and Month 6 (study termination)
Sleep efficiency (SE) obtained by sleep diary
Time frame: Every night between starting of sleep diary completion (Day 0) and Month 6 (study termination)
Sleep latency obtained by sleep diary
Time frame: Every night between starting of sleep diary completion (Day 0) and Month 6 (study termination)
Insomnia Severity Scale (ISI) score
Time frame: On Day 0, Week 5, Week 7, Month 4, Month 6
EQ-5-D
Time frame: On Day 0, Week 5, Week 7, Week 10, Month 4, Month 6
The Presleep State Arousal Scale (PSAS)
Time frame: On Day 0, Week 5, Week 7, Week 10, Month 4, Month 6
Hospital Anxiety and Depression Scale (HAD)
Time frame: On Day 0, Week 5, Week 7, Week 10, Month 4, Month 6
Short Version of the Functional Outcomes of Sleep Questionnaire (FOSQ)
Time frame: On Day 0, Week 5, Week 7, Week 10, Month 4, Month 6
Rate of discontinuation and rate of reduction of anxiolytic hypnotic drugs and hypnotics
Time frame: On Day 0, Week 5, Week 7, Week 10, Month 4, Month 6
Acceptability E-scale (AES)
Time frame: On week 10 (after computerized behavioral therapy program)
Client Satisfaction Questionnaire (CSQ-8)
Time frame: On week 10 (after computerized behavioral therapy program)
Sleep Condition Indicator (SCI)
Time frame: On Day 0
The Pittsburgh Sleep Quality Index (PSQI)
Time frame: On Day 0
Cognitive Scale of Attachment to Benzodiazepines ("Echelle cognitive d'attachement aux benzodiazépines" ECAB)
Time frame: On Day 0
The Munich ChronoType Questionnaire (MCTQ)
Time frame: On Day 0
The Epworth Sleepiness Scale (ESS)
Time frame: On Day 0
Freiburg Mindfulness Inventory - short version (FMI)
Time frame: On Day 0
Krueger's personality inventory for DSM-5 in its brief form (PID-5-BF)
Time frame: On Day 0
The Arousal Predisposition Scale (APS)
Time frame: On Day 0
The Ford Insomnia to Stress Scale (FIRST)
Time frame: On Day 0
The "locus of control for technology"-questionnaire ("Kontrollüberzeugungen im Umgang mit Technik" - KUT)
Time frame: On Day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Arthur MICOULAUD-FRANCHI, MDPhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized behavioral therapy program delivered by internet for insomnia management and Spa treatment in people with Insomnia, run by Association Francaise pour la Recherche Thermale at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Arthur MICOULAUD-FRANCHI, MDPhD (557820173 ext. +33, jean-arthur.micoulaud-franchi@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Scale (ISI) score (time frame: Week 10 = 8 weeks after beginning of computerized behavioral therapy (starting of time in bed restriction)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2022.