Study of the Effect of Spa Therapy on Insomnia (Somn'eau)

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 Overview

• Status: Not yet recruiting
• Conditions: Insomnia
• Intervention / Treatment: Other: Thermal spa treatment

• Study Type: Observational
• Enrollment (Estimated): 270

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Immunocompromised patients
• Patients with chronic inflammatory rheumatic disease during an active flare
• Severe general health impairment, including cachexia

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Insomia Cohort

Other: Thermal spa treatment; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	At baseline (Day 0), and Day 18 (end of treatment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nighttime sleep duration	Total nighttime sleep duration during a typical night, self-reported by the participant and expressed in hours.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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).	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.	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.	At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment

Collaborators and Investigators

• Sponsor: Clinique Beau Soleil

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: February 26, 2026
• First Submitted That Met QC Criteria: March 10, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 2025-A00295-44

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No