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NCT Number: NCT07473011

Study of the Effect of Spa Therapy on Insomnia

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thermal spa treatment

Other

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Nighttime sleep duration

    Time frame: At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment

    Total nighttime sleep duration during a typical night, self-reported by the participant and expressed in hours.

  2. Number of nocturnal awakenings

    Time frame: At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment.

    Number of awakenings occurring during a typical night of sleep, self-reported by the participant and expressed as the number of awakenings per night.

  3. Sleep satisfaction

    Time frame: At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment.

    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.

  4. Pain Assessment Scale

    Time frame: At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment

    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.

  5. Hospital Anxiety and Depression Scale

    Time frame: At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment

    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.

  6. Pichot Fatigue Scale

    Time frame: At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment

    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.

  7. Epworth Sleepiness Scale

    Time frame: At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment

    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.

  8. EuroQol 5 Dimensions

    Time frame: At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment

    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.

  9. EuroQol Visual Analogue Scale

    Time frame: At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment

    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.

  10. Clinical Global Impression - Improvement Scale

    Time frame: At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment

    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.

  11. Perceived Stress Scale

    Time frame: At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment

    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).

  12. International Restless Legs Syndrome Severity Scale

    Time frame: At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment

    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.

  13. Physical Activity Questionnaire

    Time frame: At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment

    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.

Sponsors and collaborators

Lead sponsor

Clinique Beau Soleil

Other

Registry information

Acronym: Somn'eau

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Mar 16, 2026
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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