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Not yet recruiting NCT07473011

Study of the Effect of Spa Therapy on Insomnia

— Observational Insomnia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Thermal spa treatment.
Who it may be relevant to
Registry conditions: Insomnia. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Insomnia Severity Index [Time frame: At baseline (Day 0), and Day 18 (end of treatment)]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07473011 · 2025-A00295-44

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗