Validation of the Single-item Sleep Quality Scale

NCT06612853 | Recruiting

• 1 other identifier: WS-0105
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

The single-item sleep quality scale (SQS) allows patients to provide a self-assessment of sleep quality over a 7-day recall period without significant additional burden. However, the SQS has not yet been utilized or validated in patients with spine pathologies. The main purpose of this study is to cross-culturally adapt the SQS from English to German and Italian and to test its validity in patients with back disorders. The study will be conducted in two stages. The first stage will involve the translation and cross-cultural adaptation of the SQS from English to German and Italian. The second stage will involve the evaluation of the instrument's face, content, and construct validity, reproducibility, and responsiveness in patients with back disorders.

Conditions

Spine Disorder

Keywords

Cross cultural adaptation; Translation; Validity; Reproducebility; Responsiveness; SQS; Sleep quality

Outcome Measures

Primary Outcomes (4)

• Translation and cross-cultural adaptation of the Single-item Sleep Quality Scale (SQS) in Italian and German

  Outcome: translated version of the SQS in Italian and German

  Within 8 weeks following the enrollment of the translators and expert commitee for the translation process.

• Field-testing of the Single-item Sleep Quality Scale (SQS) final translated version for responsiveness

  SQS responsiveness. A ROC curve analysis will be used to explore the ability of the SQS change scores to differentiate between patients who have and have not improved (dichotomized), according to the Pittsburgh Sleep Quality Index (PSQI) delta scores of Item 6 (sleep quality). Using the ROC curve, the responsiveness will be described in terms of sensitivity and specificity. We will consider an AUC of at least 0.70 to be adequate. The optimal cut off point will be computed using the Youden index.

  At 3 months (week 12) after treatment (surgical or conservative)

• Field-testing of the Single-item Sleep Quality Scale (SQS) final translated version for construct validity

  SQS construct validity. Outcome: the construct validity will be calculated through Spearman\'s correlation coefficient between SQS score (from 0 to 10) and the questionnaire item 6 (sleep quality) of the Pittsburgh Sleep Quality Index (PSQI). The strength of the relationship will be described as excellent (0.81-1.0), very good (0.61-0.80), good (0.41-0.60), fair (0.21-0.40), and poor (0.20-0.0).

  At week 1, before treatment.

• Pilot-testing of the Single-item Sleep Quality Scale (SQS) pre-final translated version for content validity

  SQS content validity Outcome: the content validity ratio (CVR). CVR will be calculated as follows: CVR= \[ne - (N/2)\] / (N/2), where ne is the number of experts indicating an item "essential," and N is the total number of experts. Therefore, considering the sample size (n=20) for pilot testing and the recognized Lawshe\'s CVR critical values, a CVR value of 0.50 is expected (corresponding to a 75% of agreement).

  Within 8 weeks from the enrollment of the patients. Patients will be recruited immediately after their outpatient examination and they will fill in the SQS once.

Study Arms (2)

Pilot testing

A sample of n=20 Italian-speaking spine patients will complete the pre-final Italian version of the SQS and then be interviewed to discuss linguistic clarity and relevance. The same process will be performed with native German speakers for the German versions of the SQS

Other: Sleep Quality Scale (SQS)

Field testing

A sample of n=100 Italian-speaking spine patients will complete the final translated Italian version of the SQS, together with the PSQI. The same process will be performed for n=100 German-speaking patients.

Other: Sleep Quality Scale (SQS); Other: Pittsburgh Sleep Quality Index (PSQI)

Interventions

Sleep Quality Scale (SQS) OTHER

For the pilot testing, each patient will complete the pre-final version of the SQS. The patients involved in the field study will have to fill in the SQS twice before treatment, one week apart, to assess reproducibility of the scale and a third time at 3 months after treatment (surgical or conservative) to assess the responsiveness of the scale.

Field testing; Pilot testing

Pittsburgh Sleep Quality Index (PSQI) OTHER

The patients involved in the field test will have to fill in the PSQI twice before treatment, one week apart, to assess reproducibility of the scale and a third time at 3 months after treatment (surgical or conservative) to assess the responsiveness of the scale.

Field testing

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with spinal disorders, being considered for spinal surgery or conservative treatment, and with a good understanding of the German or Italian language will be recruited at the Schulthess Clinic. For the pilot testing, patients will be recruited immediately after their outpatient examination. For the field testing, patients waiting for surgery or conservative treatment will be recruited. A total of 20 patients, complying with the inclusion and exclusion criteria listed above, will be involved in the pilot test and a total of 100 patients will be involved in the field test. Therefore, n=120 patients will be recruited for each language translation, with a total of n=240 patients.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Schulthess Klinik: lead

Study Sites (1)

Schulthess Klinik

Zurich, Canton of Zurich, 8008, Switzerland

RECRUITING

Related Publications (9)

• Mannion AF, Porchet F, Kleinstuck FS, Lattig F, Jeszenszky D, Bartanusz V, Dvorak J, Grob D. The quality of spine surgery from the patient's perspective. Part 1: the Core Outcome Measures Index in clinical practice. Eur Spine J. 2009 Aug;18 Suppl 3(Suppl 3):367-73. doi: 10.1007/s00586-009-0942-8. Epub 2009 Mar 25.

  PMID: 19319578 BACKGROUND

• Mannion AF, Mariaux F, Reitmeir R, Fekete TF, Haschtmann D, Loibl M, Jeszenszky D, Kleinstuck FS, Porchet F, Elfering A. Development of the "Core Yellow Flags Index" (CYFI) as a brief instrument for the assessment of key psychological factors in patients undergoing spine surgery. Eur Spine J. 2020 Aug;29(8):1935-1952. doi: 10.1007/s00586-020-06462-z. Epub 2020 Jun 16.

  PMID: 32556625 BACKGROUND

• Szentkiralyi A, Madarasz CZ, Novak M. Sleep disorders: impact on daytime functioning and quality of life. Expert Rev Pharmacoecon Outcomes Res. 2009 Feb;9(1):49-64. doi: 10.1586/14737167.9.1.49.

  PMID: 19371179 BACKGROUND

• Littner M, Kushida CA, Anderson WM, Bailey D, Berry RB, Davila DG, Hirshkowitz M, Kapen S, Kramer M, Loube D, Wise M, Johnson SF; Standards of Practice Committee of the American Academy of Sleep Medicine. Practice parameters for the role of actigraphy in the study of sleep and circadian rhythms: an update for 2002. Sleep. 2003 May 1;26(3):337-41. doi: 10.1093/sleep/26.3.337.

  PMID: 12749556 BACKGROUND

• Littner M, Hirshkowitz M, Kramer M, Kapen S, Anderson WM, Bailey D, Berry RB, Davila D, Johnson S, Kushida C, Loube DI, Wise M, Woodson BT; American Academy of Sleep Medicine; Standards of Practice Committe. Practice parameters for using polysomnography to evaluate insomnia: an update. Sleep. 2003 Sep;26(6):754-60. doi: 10.1093/sleep/26.6.754.

  PMID: 14572131 BACKGROUND

• Krystal AD, Edinger JD. Measuring sleep quality. Sleep Med. 2008 Sep;9 Suppl 1:S10-7. doi: 10.1016/S1389-9457(08)70011-X.

  PMID: 18929313 BACKGROUND

• Lomeli HA, Perez-Olmos I, Talero-Gutierrez C, Moreno CB, Gonzalez-Reyes R, Palacios L, de la Pena F, Munoz-Delgado J. Sleep evaluation scales and questionaries: a review. Actas Esp Psiquiatr. 2008 Jan-Feb;36(1):50-9.

  PMID: 18286400 BACKGROUND

• Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

  PMID: 2748771 BACKGROUND

• Snyder E, Cai B, DeMuro C, Morrison MF, Ball W. A New Single-Item Sleep Quality Scale: Results of Psychometric Evaluation in Patients With Chronic Primary Insomnia and Depression. J Clin Sleep Med. 2018 Nov 15;14(11):1849-1857. doi: 10.5664/jcsm.7478.

  PMID: 30373688 BACKGROUND

MeSH Terms

Conditions

Spinal Diseases; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Jacopo Vitale, Dr. PhD

CONTACT

0443857148; jacopo.vitale@kws.ch

Fabio Galbusera, Eng PhD

CONTACT

0443857148; fabio.galbusera@kws.ch

Study Design

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

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: September 25, 2024
• Study Start: October 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: December 31, 2025
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)