Study of the Effect of Spa Therapy on Insomnia

NCT07473011 | Not Yet Recruiting

• 1 other identifier: 2025-A00295-44
• Study Type: observational
• Target: 270
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Nighttime sleep duration

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

• Number of nocturnal awakenings

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

• Sleep satisfaction

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

• Pain Assessment Scale

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

• Hospital Anxiety and Depression Scale

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

Study Arms (1)

Insomia Cohort

Other: Thermal spa treatment

Interventions

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.

Insomia Cohort

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinique Beau Soleil: lead

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 16, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: March 16, 2026

Record last verified: 2026-02