Validation of a sleep quality assessment tool for spine disorder patients
Cross-cultural Adaptation Into German and Italian, Validation, Reproducibility, and Responsiveness of the Single-item Sleep Quality Scale in Spine Patients
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 type | Observational |
|---|---|
| Enrollment | 240 (estimated) |
| Ages | 14 Years and up |
| Sex | All |
| Sponsor | Schulthess Klinik Academic / other |
| Locations | 1 site (Zurich, Canton of Zurich) |
| Trial ID | NCT06612853 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are German-speaking or Italian-speaking patients aged 14 and older with a diagnosis of spine pathology.
Not a fit: Patients who are pregnant, undergoing treatment for sleep disorders, or unable to provide informed consent may not benefit from this study.
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 performed: Other studies have successfully validated similar patient-reported outcome measures, indicating a promising approach for this validation effort.
Eligibility criteria
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 this trial is running
Zurich, Canton of Zurich
- Schulthess Klinik — Zurich, Canton of Zurich, Switzerland (Recruiting)
Study contacts
- Study coordinator: Jacopo Vitale, Dr. PhD
- Email: jacopo.vitale@kws.ch
- Phone: 0443857148
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.