Clinical trial Recruiting at 1 site Observational Ages 14 and up

Validation of a sleep quality assessment tool for spine disorder patients

Official title: Cross-cultural Adaptation Into German and Italian, Validation, Reproducibility, and Responsiveness of the Single-item Sleep Quality Scale in Spine Patients

Run by Schulthess Klinik · NCT06612853 · Data updated 2026-11-12

This study is testing a new sleep quality questionnaire for people with spine disorders to see if it works well in German and Italian.

Quick facts

Study typeObservational
Ages14 Years and up
SexAll
Enrollment240 (estimated)
SponsorSchulthess Klinik
Academic / other
Locations1 site (Zurich, Canton of Zurich)
StatusRecruiting
StartedOctober 1, 2024
Main results expectedOctober 1, 2025
Study endsDecember 31, 2025
Registry record updatedNovember 29, 2024
Trial IDNCT06612853 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are German-speaking or Italian-speaking patients aged 14 and older with a diagnosis of spine pathology.

Probably not a fit

Patients who are pregnant, undergoing treatment for sleep disorders, or unable to provide informed consent may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to validate the Single-item Sleep Quality Scale (SQS) for patients with spine disorders by translating it into German and Italian. The research will be conducted in two stages: first, the translation and cross-cultural adaptation of the SQS, followed by an evaluation of its validity, reproducibility, and responsiveness in assessing sleep quality among these patients. By utilizing this tool, healthcare providers can better understand the impact of sleep quality on patients suffering from back disorders. The study addresses a significant gap in the assessment of sleep quality in this population.

Why it matters

Potential benefit: If successful, this study could provide a reliable and culturally adapted tool for assessing sleep quality in patients with spine disorders, leading to improved patient care.

How similar studies have gone: Other studies have successfully validated similar patient-reported outcome measures, indicating a promising approach for this validation effort.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* both male and female patients
* German-speaking or Italian-speaking
* diagnosis of spine pathology
* age ≥ 14 years
* cognitively intact (self-reported)

Exclusion Criteria:

* pregnancy (self-reported)
* medical and/or pharmacological treatment for sleep disorders
* melatonin intake
* daily use of smart-watch or applications for automatic sleep detection
* inability to give informed consent

Where it's running

  • Schulthess Klinik
    Zurich, Canton of Zurich, Switzerland
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.