Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06612853
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
Validation of the Single-item Sleep Quality Scale
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Cross-cultural Adaptation Into German and Italian Validation Reproducibility and Responsiveness of the Single-item Sleep Quality Scale in Spine Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SQS
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 instruments face content and construct validity reproducibility and responsiveness in patients with back disorders
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 34core34 yellow flags depression anxiety catastrophizing and fear-avoidance has been developed and defined as the 34Core Yellow Flags Index34 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 andor 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 andor 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 9342EEC and the ISO Norm 14155 and ISO 14971 the Swiss Law and Swiss regulatory authoritys 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 stopend in agreement with local requirements
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 andor 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 andor 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 9342EEC and the ISO Norm 14155 and ISO 14971 the Swiss Law and Swiss regulatory authoritys 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 stopend in agreement with local requirements
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None