InsomniaSomn'eauNCT07473011
Study of the Effect of Spa Therapy on Insomnia
An observational study of Insomnia, run by Clinique Beau Soleil.
Trial summary
Many spa patients report falling asleep more easily, experiencing fewer nighttime awakenings, and feeling more refreshed upon waking after their treatment. However, these effects have never been formally evaluated in a scientific study. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Insomnia
- What is being tested?
- Thermal spa treatment
- How many people
- 270 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 1 Mar 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be selected from all patients admitted for a prescribed 18-day thermal spa treatment at Balaruc-les-Bains as part of their usual medical care, regardless of therapeutic orientation (rheumatology, phlebology, or combined orientation). Eligible participants are adults aged 18 to 90 years, affiliated with the French Social Security system or an equivalent healthcare coverage, and presenting symptoms of insomnia defined by an Insomnia Severity Index (ISI) score ≥ 8. Patients will be informed about the study by their thermal spa physician and the spa medical staff. Inclusion will occur after verification of eligibility criteria and signature of a non-opposition form. Individuals with cognitive impairment, inability to complete questionnaires in French, deprivation of liberty, legal guardianship, or medical contraindications to spa treatment will not be included.
Who may be able to join
- Individuals following an 18-day thermal spa program
- Signed non-opposition form
- Affiliation with the French Social Security system or an equivalent healthcare coverage
- Insomnia Severity Index (ISI) score ≥ 8
Who cannot join
- Individuals deprived of their liberty by law
- Individuals under legal guardianship or trusteeship
- Individuals with cognitive impairment
- Individuals unable to complete written questionnaires in French
- Uncontrolled cardiovascular disease
- Active infectious condition
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- Immunocompromised patients
- Patients with chronic inflammatory rheumatic disease during an active flare
- Severe general health impairment, including cachexia
About this study
Many spa patients report falling asleep more easily, experiencing fewer nighttime awakenings, and feeling more refreshed upon waking after their treatment. However, these effects have never been formally evaluated in a scientific study. The aim of this study is therefore to measure precisely the impact of the spa treatment on the severity of insomnia.
The study does not modify usual care. Participants follow their prescribed spa treatment as planned. They are simply asked to complete questionnaires:
Read more
- before the start of the treatment
- at the end of the 18-day program
- and 2 months later
The main questionnaire assesses the severity of insomnia. Additional questionnaires evaluate sleep quality, fatigue, pain, anxiety, stress, and quality of life.
- Conditions
- Insomnia
- Being tested
- Thermal spa treatment
- 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.
Thermal spa treatmentOther
The thermal spa center in Balaruc-les-Bains offers 15 different thermal treatments tailored to each patient's specific needs. A structured protocol of four daily treatments over 18 days is established for each patient to ensure appropriate care. These treatments may be adjusted during the course of the spa program without compromising therapeutic objectives. They are divided into two categories according to the temperature of the thermal water used.
| Study group | Role | What they receive |
|---|---|---|
| Insomia Cohort | Not described Receives: Other: Thermal spa treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index
This instrument assesses the severity and consequences of insomnia through 5 questions. Each item is rated on a five-point Likert scale ranging from 0 to 4. Higher total scores indicate greater insomnia severity (0-7: no insomnia; 8-14: subthreshold insomnia; 15-21: moderate insomnia; 22-28: severe insomnia).
Measured: At baseline (Day 0), and Day 18 (end of treatment)
Secondary outcomes (13)
Nighttime sleep duration
Total nighttime sleep duration during a typical night, self-reported by the participant and expressed in hours.
Measured: At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment
Number of nocturnal awakenings
Number of awakenings occurring during a typical night of sleep, self-reported by the participant and expressed as the number of awakenings per night.
Measured: At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment.
Sleep satisfaction
Overall sleep satisfaction assessed using a visual numeric scale ranging from 0 (very poor sleep quality) to 10 (excellent sleep quality), expressed as a score from 0 to 10.
Measured: At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment.
Pain Assessment Scale
Pain will be assessed using a Visual Numeric Rating Scale (NRS). This self-assessment tool is simple, reproducible, and sensitive to changes in pain intensity. It provides a quantitative yet subjective measure of pain.
The numeric rating scale ranges from 0 to 10, where 0 corresponds to no pain and 10 to the worst imaginable pain. Participants select the number that best represents their current level of pain. The chosen number reflects the intensity of pain experienced.
Measured: At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment
Hospital Anxiety and Depression Scale
The Hospital Anxiety and Depression Scale (HADS) is a screening tool used to assess levels of anxiety and depression in patients. It consists of 14 items divided into two subscales: 7 items for anxiety (HADS-A) and 7 items for depression (HADS-D). Each item is scored from 0 to 3, resulting in a total score ranging from 0 to 21 for each subscale.
Measured: At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment
Pichot Fatigue Scale
The Pichot Fatigue Scale is a self-assessment tool used to measure physical and mental fatigue in individuals. It is commonly used in the follow-up of patients with chronic conditions, psychiatric disorders such as depression, or chronic fatigue syndromes.
The scale consists of 8 items, each rated from 0 to 4 according to the intensity of the symptom experienced. It is a simple, quick instrument (less than 5 minutes to complete) and provides a reliable measure to quantify fatigue and monitor its evolution over time.
Measured: At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment
Epworth Sleepiness Scale
The Epworth Sleepiness Scale assesses a patient's likelihood of falling asleep in eight everyday situations. It measures daytime sleepiness. A total score greater than 10 is considered indicative of excessive daytime sleepiness.
Measured: At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment
EuroQol 5 Dimensions
The EQ-5D-5L is a self-administered questionnaire assessing health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension includes five severity levels ranging from no problems to extreme problems/unable to perform. Responses define a five-digit health state that can be converted into a utility index score ranging from values below 0 to 1.00, with higher scores indicating better health status.
Measured: At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment
EuroQol Visual Analogue Scale
Perceived health is assessed using the EQ Visual Analogue Scale (EQ-VAS), ranging from 0 (worst imaginable health state) to 100 (best imaginable health state), with higher scores indicating better perceived health.
Measured: At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment
Clinical Global Impression - Improvement Scale
The Clinical Global Impression - Improvement scale assesses overall change in a patient's clinical condition following an intervention compared with baseline. Scores range from 1 (very much improved) to 7 (very much worse), with lower scores indicating greater improvement.
Measured: At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment
Perceived Stress Scale
The Perceived Stress Scale (PSS-10), developed by Cohen, Kamarck, and Mermelstein in 1983, is a psychometric instrument used to measure the level of stress perceived by an individual over the past month.
It consists of 10 items derived from the original 14-item version (PSS-14). The scale assesses subjective stress perception by evaluating the frequency of stress-related thoughts and feelings. Responses are rated on a scale from 0 (never) to 4 (very often).
Measured: At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment
International Restless Legs Syndrome Severity Scale
The International Restless Legs Syndrome Rating Scale IRLS assesses the severity of restless legs syndrome by evaluating symptom intensity frequency and impact on daily functioning and quality of life. The score ranges from 0 to 40 with higher scores indicating greater symptom severity.
Measured: At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment
Physical Activity Questionnaire
The Ricci and Gagnon Physical Activity Questionnaire assesses an individual's level of physical activity using questions on the frequency intensity and duration of daily activities. The total score ranges from 0 to 45 with higher scores indicating higher levels of physical activity. Scores lower than 18 indicate inactivity scores between 18 and 35 indicate an active lifestyle and scores above 35 indicate a very active lifestyle.
Measured: At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2029 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Beau Soleil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07473011
- Sponsor's protocol ID
- 2025-A00295-44
- Acronym
- Somn'eau
- Status last verified
- Feb 2026
- First submitted
- 26 Feb 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effect of Spa Therapy on Insomnia
- ClinicalTrials.gov ID
- NCT07473011
- Acronym / sponsor ID
- Somn'eau / 2025-A00295-44
- Conditions
- Insomnia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Clinique Beau SoleilUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 16 Mar 2026 (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.
Many spa patients report falling asleep more easily, experiencing fewer nighttime awakenings, and feeling more refreshed upon waking after their treatment. However, these effects have never been formally evaluated in a scientific study. The aim of this study is therefore to measure precisely the impact of the spa treatment on the severity of insomnia.
The study does not modify usual care. Participants follow their prescribed spa treatment as planned. They are simply asked to complete questionnaires:
- before the start of the treatment
- at the end of the 18-day program
- and 2 months later
The main questionnaire assesses the severity of insomnia. Additional questionnaires evaluate sleep quality, fatigue, pain, anxiety, stress, and quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Insomia Cohort | – | Other: Thermal spa treatment |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be selected from all patients admitted for a prescribed 18-day thermal spa treatment at Balaruc-les-Bains as part of their usual medical care, regardless of therapeutic orientation (rheumatology, phlebology, or combined orientation). Eligible participants are adults aged 18 to 90 years, affiliated with the French Social Security system or an equivalent healthcare coverage, and presenting symptoms of insomnia defined by an Insomnia Severity Index (ISI) score ≥ 8. Patients will be informed about the study by their thermal spa physician and the spa medical staff. Inclusion will occur after verification of eligibility criteria and signature of a non-opposition form. Individuals with cognitive impairment, inability to complete questionnaires in French, deprivation of liberty, legal guardianship, or medical contraindications to spa treatment will not be included.
Key inclusion criteria (4 listed)
- Individuals following an 18-day thermal spa program
- Signed non-opposition form
- Affiliation with the French Social Security system or an equivalent healthcare coverage
- Insomnia Severity Index (ISI) score ≥ 8
Key exclusion criteria (9 listed)
- Individuals deprived of their liberty by law
- Individuals under legal guardianship or trusteeship
- Individuals with cognitive impairment
- Individuals unable to complete written questionnaires in French
- Uncontrolled cardiovascular disease
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 |
|---|---|---|
| Thermal spa treatmentThe thermal spa center in Balaruc-les-Bains offers 15 different thermal treatments tailored to each patient's specific needs. A structured protocol of four daily treatments over 18 days is established for each patient to ensure appropriate care. These treatments may be adjusted during the course of the spa program without compromising therapeutic objectives. They are divided into two categories according to the temperature of the thermal water used. | Other | Insomia Cohort |
Primary outcome
Insomnia Severity Index
Time frame: At baseline (Day 0), and Day 18 (end of treatment)
This instrument assesses the severity and consequences of insomnia through 5 questions. Each item is rated on a five-point Likert scale ranging from 0 to 4. Higher total scores indicate greater insomnia severity (0-7: no insomnia; 8-14: subthreshold insomnia; 15-21: moderate insomnia; 22-28: severe insomnia).
13 secondary outcomes
Nighttime sleep duration
Time frame: At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment
Number of nocturnal awakenings
Time frame: At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment.
Sleep satisfaction
Time frame: At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment.
Pain Assessment Scale
Time frame: At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment
Hospital Anxiety and Depression Scale
Time frame: At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment
Pichot Fatigue Scale
Time frame: At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment
Epworth Sleepiness Scale
Time frame: At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment
EuroQol 5 Dimensions
Time frame: At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment
EuroQol Visual Analogue Scale
Time frame: At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment
Clinical Global Impression - Improvement Scale
Time frame: At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment
Perceived Stress Scale
Time frame: At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment
International Restless Legs Syndrome Severity Scale
Time frame: At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment
Physical Activity Questionnaire
Time frame: At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Insomnia, run by Clinique Beau Soleil.
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 4 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: opening soon, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (time frame: At baseline (Day 0), and Day 18 (end of treatment)). 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 16 Mar 2026.