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

Clinique Beau Soleil

Status: Begins enrollment this month

Conditions: Insomnia

Treatments: Other: Thermal spa treatment

Study type: Observational

Funder types: Other

Identifiers

NCT07473011

2025-A00295-44

Details and patient eligibility

About

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.

Enrollment: 270 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

270 participants in 1 patient group

Insomia Cohort

Treatment:

Other: Thermal spa treatment