Validation of the Single-item Sleep Quality Scale (SQS)

November 26, 2024 updated by: Schulthess Klinik

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Low back pain (LBP) consistently ranks as the leading cause of disability globally, prompting individuals affected by LBP to frequently seek healthcare. Utilizing reliable Patient-Reported Outcome Measures (PROMs) aids healthcare providers in assessing pain, functional impairment, disability, satisfaction, and quality of life in a standardized manner. However, the use of a validated questionnaire to assess each of these domains is not practicable in clinical practice. To solve this problem, the multidimensional Core Outcome Measures Index (COMI) was developed to assess the impact of LBP, using a brief set of questions. COMI has been demonstrated as a valuable metric when compared to alternative methods, exhibiting no significant limitations in terms of floor or ceiling effects and demonstrating outstanding construct validity. Moreover, it has also been established as a sensitive tool for assessing the perceived changes in patients following treatment. Recently, a complementary set of single-item measures to assess four of the "core" yellow flags (depression, anxiety, catastrophizing, and fear-avoidance) has been developed and defined as the "Core Yellow Flags Index" (CYFI). THE CYFI has been proven to be a valid and brief instrument for the assessment of key psychological factors in patients undergoing spine surgery and it also made a relevant contribution in predicting postoperative outcomes in this population. The brevity of the CYFI makes it a useful addition to the COMI in the self-assessment of baseline status before surgery.

Curiously, sleep has rarely been studied in this population and both the COMI and the CYFI do not evaluate this important variable. Assessing sleep in patients affected by spine disorders, including LBP, is of paramount importance due to the significant impact sleep disturbances can have on both the progression and management of these conditions. Sleep plays a crucial role in various physiological processes, including pain modulation, tissue repair, immune function, and psychological well-being. Therefore, disruptions in sleep patterns can exacerbate symptoms, impair recovery, and diminish the overall quality of life for individuals with back disorders. Recognizing the substantial impact of sleep-related challenges on individuals and their consequential implications, it becomes crucial to employ tools for assessing sleep quality in clinical settings.

Sleep assessment involves the measurement of various parameters, including sleep duration, sleep architecture, sleep latency, and the frequency and duration of nocturnal awakenings. Objective methods such as polysomnography (PSG) and/or actigraphy, or the use of sleep-rating questionnaires, are typically employed to quantitatively assess these metrics. The established benchmark for evaluating sleep quality continues to be PSG and/or electroencephalographic spectral analysis, despite the effectiveness of behavioural parameters in certain contexts, such as actigraphy. However, both PSG and EEG analyses may pose logistical challenges in large-scale and field studies. To address these constraints and to obtain preliminary insights into potential sleep disorders in different populations, several sleep questionnaires have been formulated and validated. Despite their efficacy in gauging sleep quality, these tools exhibit limitations when applied in clinical trials. A case in point is the Pittsburgh Sleep Quality Index (PSQI), a commonly utilized measure for assessing sleep quality, since its extended format incorporating 19 rating items may render it impractical for administration to participants in clinical trials. Further, the PSQI exhibits limitations due to its utilization of only four potential response levels for the sleep quality question. This constraint could restrict respondents when assigning grades to their sleep quality, potentially compromising the precision of their responses. Moreover, such a limited scale may fail to capture minor or nuanced changes in sleep quality. Consequently, despite the existence of alternative sleep quality questionnaires, there persists a requirement to create and validate innovative instruments explicitly tailored for assessing sleep quality in the framework of clinical trials. These novel questionnaires should address the shortcomings associated with response level constraints to enhance the accuracy and sensitivity of sleep quality evaluations in research settings.

Recently, the single-item sleep quality scale (SQS) was developed as a simple and practical sleep quality assessment. The authors reported that the SQS possesses excellent concurrent criterion validity and strong correlations between the SQS and the sleep quality items of the PSQI in patients with insomnia were detected. The SQS represents a pragmatic advancement in sleep quality assessment within clinical settings, distinguishing itself from conventional standards. Developed as a self-rated global tool, SQS offers an efficient approach based on a comprehensive review of pertinent sleep quality aspects, incorporating critical components from the PSQI, and incorporating expert and patient feedback. The single-item format permits patients to provide a self-assessment of sleep quality over a 7-day recall period without significant additional burden. Employing a visual analogue scale (VAS) enhances the potential for a more sensitive measurement, contributing to the utility of SQS in capturing nuanced variations in sleep quality. This innovation addresses the need for a streamlined yet effective tool for sleep quality evaluation in clinical contexts. However, the SQS has not yet been adapted for the German and Italian languages, nor it has been validated in spine patients.

Regarding risk category, the project shall be identified as Category A (only minimal risk and burden regarding the planned measures for sampling biological material or collecting personal data). The rationale for the categorization is based on the study objectives and study design.

This project will be carried out in accordance with the protocol and with principles enunciated in the current version of the Declaration of Helsinki, the guidelines of Good Clinical Practice (GCP) issued by ICH, in case of medical device: the European Directive on medical devices 93/42/EEC and the ISO Norm 14155 and ISO 14971, the Swiss Law and Swiss regulatory authority's requirements. The approval will be sought from the local responsible independent Competent Ethics Committee (CEC) in Zurich. In accordance with GCP, the project will be implemented only after obtaining approval for this protocol, and other study-specific documents by the local responsible independent CEC. Participants consenting to participate in the study will be enrolled. The CEC will be informed about study stop/end in agreement with local requirements.

Study Type

Observational

Enrollment (Estimated)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
    • ZH
      • Zürich, ZH, Switzerland, 8008
        • Recruiting
        • Schulthess Klinik
        • Contact:
          • Jacopo Vitale, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)

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
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)

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.

Other: Pittsburgh Sleep Quality Index (PSQI)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Translation and cross-cultural adaptation of the Single-item Sleep Quality Scale (SQS) in Italian and German
Time Frame: Within 8 weeks following the enrollment of the translators and expert commitee for the translation process.
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
Time Frame: At 3 months (week 12) after treatment (surgical or conservative)
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
Time Frame: At week 1, before treatment.

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
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Schulthess Klinik

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

August 8, 2024

First Submitted That Met QC Criteria

September 24, 2024

First Posted (Actual)

September 25, 2024

Study Record Updates

Last Update Posted (Actual)

November 29, 2024

Last Update Submitted That Met QC Criteria

November 26, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WS-0105

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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