scholarly journals Test–Retest Reliability and Responsiveness of PROMIS Sleep Short Forms Within an RCT in Women With Fibromyalgia

2021 ◽  
Vol 2 ◽  
Author(s):  
Ruth L. Chimenti ◽  
Barbara A. Rakel ◽  
Dana L. Dailey ◽  
Carol G. T. Vance ◽  
Miriam B. Zimmerman ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sleep Disturbance ◽  
Treatment Time ◽  
Total Sleep Time ◽  
Sleep Time ◽  
Sleep Efficiency ◽  
Retest Reliability ◽  
Short Forms ◽  
Test Retest Reliability ◽  
Restorative Sleep

Background: Nonrestorative sleep is commonly reported by individuals with fibromyalgia, but there is limited information on the reliability and responsiveness of self-reported sleep measures in this population.Objectives: (1) Examine the reliability and validity of the Patient-Reported Outcomes Measurement Information System (PROMIS) sleep measures in women with fibromyalgia, and (2) Determine the responsiveness of the PROMIS sleep measures to a daily transcutaneous electrical nerve stimulation (TENS) intervention in women with fibromyalgia over 4 weeks compared with other measures of restorative sleep.Methods: In a double-blinded, dual-site clinical trial, 301 women with fibromyalgia were randomly assigned to utilize either Active-TENS, Placebo-TENS, or No-TENS at home. Measures were collected at baseline and after 4 weeks of treatment. To assess self-reported sleep, the participants completed three PROMIS short forms: Sleep Disturbance, Sleep-Related Impairment, Fatigue, and the Pittsburgh Sleep Quality Index (PSQI). To assess device-measured sleep, actigraphy was used to quantify total sleep time, wake after sleep onset, and sleep efficiency. Linear mixed models were used to examine the effects of treatment, time, and treatment*time interactions.Results: The PROMIS short forms had moderate test–retest reliability (ICC 0.62 to 0.71) and high internal consistency (Cronbach's alpha 0.89 to 0.92). The PROMIS sleep measures [mean change over 4 weeks, 95% confidence interval (CI)], Sleep Disturbance: −1.9 (−3.6 to −0.3), Sleep-Related Impairment: −3 (−4.6 to −1.4), and Fatigue: −2.4 (−3.9 to −0.9) were responsive to improvement in restorative sleep and specific to the Active-TENS group but not in the Placebo-TENS [Sleep Disturbance: −1.3 (−3 to 0.3), Sleep-Related Impairment: −1.2 (−2.8 to 0.4), Fatigue: −1.1 (−2.7 to 0.9)] or No-TENS [Sleep Disturbance: −0.1 (−1.6 to 1.5), Sleep-Related Impairment: −0.2 (−1.7 to 1.4), Fatigue: –.3 (−1.8 to 1.2)] groups. The PSQI was responsive but not specific with improvement detected in both the Active-TENS: −0.9 (−1.7 to −0.1) and Placebo-TENS: −0.9 (−1.7 to 0) groups but not in the No-TENS group: −0.3 (−1.1 to 0.5). Actigraphy was not sensitive to any changes in restorative sleep with Active-TENS [Sleep Efficiency: −1 (−2.8 to 0.9), Total Sleep Time: 3.3 (−19.8 to 26.4)].Conclusion: The PROMIS sleep measures are reliable, valid, and responsive to improvement in restorative sleep in women with fibromyalgia.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT01888640.

scholarly journals Study of correlation between perceived sleep disturbances in depressed patients with objective changes in sleep architecture using polysomnography before and after antidepressant therapy

2020 ◽  
Vol 8 (7) ◽  
pp. 2551
Author(s):  
Ganesh Ingole ◽  
Harpreet S. Dhillon ◽  
Bhupendra Yadav
Keyword(s):  
Sleep Disturbances ◽  
Total Sleep Time ◽  
Antidepressant Treatment ◽  
Sleep Onset ◽  
Sleep Time ◽  
Sleep Efficiency ◽  
Sleep Architecture ◽  
Wake Time ◽  
Depressed Patients ◽  
Before And After

Background: A prospective cohort study to correlate perceived sleep disturbances in depressed patients with objective changes in sleep architecture using polysomnography (PSG) before and after antidepressant therapy.Methods: Patients were recruited into the study after applying strict inclusion and exclusion criterion to rule out other comorbidities which could influence sleep. A diagnosis of Depressive episode was made based on ICD-10 DCR. Psychometry, in the form of Beck Depressive inventory (BDI) and HAMD (Hamilton depression rating scale) insomnia subscale was applied on Day 1 of admission. Patients were subjected to sleep study on Day 03 of admission with Polysomnography. Patients were started on antidepressant treatment post Polysomnography. An adequate trial of antidepressants for 08 weeks was administered and BDI score ≤09 was taken as remission. Polysomnography was repeated post remission. Statistical analysis was performed using Kruskal Wallis test and Pearson correlation coefficient.Results: The results showed positive (improvement) polysomnographic findings in terms of total sleep time, sleep efficiency, wake after sleep onset, percentage wake time and these findings were statistically significant. HAM-D Insomnia subscale was found to correlate with total sleep time, sleep efficiency, wake after sleep onset, total wake time and N2 Stage percentage.Conclusions: Antidepressant treatment effectively improves sleep architecture in Depressive disorder and HAM-D Insomnia subscale correlates with objective findings of total sleep time, sleep efficiency, wake after sleep onset, total wake time and duration of N2 stage of NREM.

Sleep disturbance and quality of life in Rheumatoid Arthritis: a prospective mobile health study (Preprint)

2021 ◽  
Author(s):  
John McBeth ◽  
William G Dixon ◽  
Susan Mary Moore ◽  
Bruce Hellman ◽  
Ben James ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Rheumatoid Arthritis ◽  
Sleep Disturbance ◽  
Mobile Health ◽  
Sleep Disturbances ◽  
Total Sleep Time ◽  
Sleep Onset ◽  
Sleep Time ◽  
Domain Scores

BACKGROUND Sleep disturbance and poor health related quality of life (HRQoL) are common in people with rheumatoid arthritis (RA). Sleep disturbances, such as less total sleep time, more waking periods after sleep onset, and higher levels of non-restorative sleep, may be a driver of HRQoL. However, understanding if these sleep disturbances reduce HRQoL has, to date, been challenging due to the need to collect complex time-varying data in high resolution. Such data collection has now been made possible by the widespread availability and use of mobile health (mHealth) technologies. OBJECTIVE In a mobile health (mHealth) study we tested whether sleep disturbance (both absolute values and variability) caused poor HRQoL. METHODS The Quality of life, sleep and rheumatoid arthritis (QUASAR) study was a prospective mHealth study of adults with RA. Participants completed a baseline questionnaire, and for 30 days wore a triaxial accelerometer to objectively assess sleep, and provided daily reports via a smartphone app of sleep (Consensus Sleep Diary (CSD)), pain, fatigue, mood, and other symptoms. Participants completed the World Health Organization Quality of Life-Brief (WHOQoL-BREF) questionnaire every 10 days. Multi-level modelling tested the relationship between sleep variables and WHOQoL-BREF domains (physical, psychological, environment and social). RESULTS Of 268 recruited participants, 254 were included in this analysis. Across all WHOQoL-BREF domains, participant’s scores were lower than the population average. CSD sleep parameters predicted WHOQoL-BREF domain scores. For example, for each hour increase in the total time asleep physical domain scores increased by 1.11 points (β = 1.11 (0.07, 2.15)) and social domain scores increased by 1.65 points. These associations were not explained by sociodemographic and lifestyle factors, disease activity, medication use, levels of anxiety, sleep quality, or clinical sleep disorders. They were, however, attenuated and no longer significant when pain, fatigue and mood were included in the model. Increased variability in the total time asleep, was associated with poorer physical and psychological domain scores independently of all covariates. There were no patterns of association between actigraphy measured sleep and WHOQoL-BREF. CONCLUSIONS Optimising total sleep time, increasing sleep efficiency, decreasing sleep onset latency, and reducing the variability in total sleep time could improve HRQoL in people with RA.

scholarly journals 1199 The Accuracy Of A New Sleep Ring Device For Tracking Sleep And Wakefulness Overnight Using Actigraphy

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A458-A459
Author(s):  
H Scott ◽  
N Lovato ◽  
L Lack
Keyword(s):  
Total Sleep Time ◽  
Sleep Time ◽  
Sleep Efficiency ◽  
Tracking Algorithm ◽  
Future Research ◽  
Sleep Laboratory ◽  
Healthy Individuals ◽  
High Agreement ◽  
Additional Funding ◽  
New Consumer

Abstract Introduction THIM is a new consumer ring-like device that can passively monitor sleep overnight using actigraphy. This project aimed to develop the THIM sleep tracking algorithm (Study 1), and test its accuracy against polysomnography (PSG) with another independent sample of good and poor sleepers (Study 2). Methods Study 1: 25 healthy individuals (15 females) aged 25.38 years (SD = 6.39) slept overnight in the sleep laboratory with THIM, the Philips Spectrum, the Fitbit Flex, and PSG recording simultaneously. The THIM sleep tracking algorithm was developed by optimising sensitivity and specificity with PSG. Study 2: An additional 20 individuals (14 females) aged 23.22 years (SD = 5.02) slept overnight in the sleep laboratory with the same devices as in Study 1. Results Study 1: THIM showed high agreement with PSG for estimating sleep (sensitivity = .91) and reasonably high agreement for wakefulness (specificity = .59). There were no significant differences between PSG and THIM for total sleep time, t(24) = 0.76, p = .46, or sleep efficiency, t(24) = 0.56, p = .58. Study 2: THIM showed high agreement with PSG for estimating sleep (sensitivity = .89) and wakefulness (specificity = .59). Compared to PSG, THIM significantly underestimated total sleep time, t(19) = 2.10, p = .049, and sleep efficiency, t(19) = 2.20, p = .04, by an average of 21.35 minutes (SD = 45.52) and 4.44% (SD = 9.04), respectively. Conclusion Together, these studies suggest that THIM is reasonably accurate for monitoring sleep overnight in healthy individuals. Slight modifications to the algorithm and additional sensors could be added to THIM to improve its accuracy. Future research will examine the accuracy of THIM with larger sample sizes and particularly for people with insomnia, with the goal being to incorporate sleep tracking into a mobile-based treatment program for insomnia. Support The project was funded in-part by the manufacturers of THIM, Re-Time Pty. Ltd. Additional funding was provided by Flinders University.

scholarly journals Electroacupuncture Treatment Normalized Sleep Disturbance in Morphine Withdrawal Rats

2011 ◽  
Vol 2011 ◽  
pp. 1-8 ◽  
Author(s):  
Yi-Jing Li ◽  
Fei Zhong ◽  
Peng Yu ◽  
Ji-Sheng Han ◽  
Cai-Lian Cui ◽  
...  
Keyword(s):  
Sleep Disturbance ◽  
Rem Sleep ◽  
Total Sleep Time ◽  
Nrem Sleep ◽  
Sleep Time ◽  
Morphine Withdrawal ◽  
Opiate Withdrawal ◽  
Important Symptom ◽  
Opiate Addicts ◽  
Retention In Treatment

Sleep disturbance is considered as an important symptom of acute and protracted opiate withdrawal. Current results suggest that sleep disturbance may be taken as a predictor of relapse. Appropriate sleep enhancement therapy will be in favor of the retention in treatment for opiate addicts. Our previous studies have shown that electroacupuncture (EA) is effective in suppressing morphine withdrawal syndrome. The aim of the present study is to investigate the effect of 2 and 100 Hz EA on the sleep disturbance during morphine withdrawal. Rats were made dependent on morphine by repeated morphine injections (escalating doses of 5–80 mg kg−1, subcutaneously, twice a day) for 5 days. EA of 2 or 100 Hz was given twice a day for 3 days, starting at 48 h after the last morphine injection. Electroencephalogram and electromyogram were monitored at the end of the first and the last EA treatments, respectively. Results showed that non-rapid eye movement (NREM) sleep, REM sleep and total sleep time decreased dramatically, while the sleep latency prolonged significantly during acute morphine withdrawal. Both 2 and 100 Hz EA produced a significant increase in NREM sleep, REM sleep and total sleep time. It was suggested that EA could be a potential treatment for sleep disturbance during morphine withdrawal.

scholarly journals Psychometric Validity, Reliability, and Responsiveness of the Tinnitus Functional Index

2018 ◽  
Vol 29 (07) ◽  
pp. 609-625 ◽  
Author(s):  
Navshika Chandra ◽  
Kevin Chang ◽  
Arier Lee ◽  
Giriraj S. Shekhawat ◽  
Grant D. Searchfield
Keyword(s):  
Clinical Trial ◽  
Psychometric Properties ◽  
Internal Consistency ◽  
Divergent Validity ◽  
Valid Measure ◽  
Functional Index ◽  
Retest Reliability ◽  
Smallest Detectable Change ◽  
Different Populations ◽  
Test Retest Reliability

AbstractThe effects of treatments on tinnitus have been difficult to quantify. The Tinnitus Functional Index (TFI) has been proposed as a standard questionnaire for measurement of tinnitus treatment outcomes. For a questionnaire to achieve wide acceptance, its psychometric properties need to be confirmed in different populations.To determine if the TFI is a reliable and valid measure of tinnitus, and if its psychometric properties are suitable for use as an outcome measure.A psychometric evaluation of the TFI from secondary data obtained from a cross-sectional clinic survey and a clinical trial undertaken in New Zealand.Confirmatory factor analysis and evaluation of internal consistency reliability were undertaken on a sample of 318 patients with the primary complaint of tinnitus. In a separate sample of 40 research volunteers, test–retest reliability, convergent and divergent validity were evaluated. Both samples consisted of predominantly older Caucasian male patients with tinnitus.The internal structure of the original US TFI was confirmed. The Cronbach’s Alpha and Intraclass correlation coefficients were >0.7 for the TFI overall and each of its subscales, indicating high internal consistency and test–retest reliability. Strong Pearson correlations with the Tinnitus Handicap Questionnaire and tinnitus numerical rating scales indicated excellent convergent validity, and a moderate correlation with the Hearing Handicap Inventory, indicated moderate divergent validity. Evaluation of the clinical trial showed good test–retest reliability and agreement between no-treatment baselines with a smallest detectable change of 4.8 points.The TFI is a reliable and valid measure of tinnitus severity in the population tested and is responsive to treatment-related change. Further research as to the TFI’s responsiveness to treatment is needed across different populations.

scholarly journals Test-Retest Reliability of the Coronary Heart Disease Damp Phlegm and Blood Stasis Pattern Questionnaire: Results from a Multicenter Clinical Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-6
Author(s):  
Ge Fang ◽  
Yaxin Wang ◽  
Zhenqian Yan ◽  
Xiaowen Zhou ◽  
Xingyu Fan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Coronary Heart Disease ◽  
Heart Disease ◽  
Blood Stasis ◽  
Reliability And Validity ◽  
Weighted Kappa ◽  
Multicenter Clinical Trial ◽  
Test Interval ◽  
Retest Reliability ◽  
Test Retest Reliability

Background. Damp phlegm and blood stasis pattern (DPBSP) is the main pattern in coronary heart disease (CHD) patients. To quantify and standardize the diagnosis of DPBSP, questionnaires are usually administered. The CHD Damp Phlegm and Blood Stasis Pattern Questionnaire (CHD-DPBSPQ) is the standard metric for measuring CHD-DPBSP signs and symptoms in practice and clinical research. The CHD-DPBSPQ has moderate diagnostic efficiency, as evidenced by its receiver operating characteristic curves. Furthermore, and high reliability and validity have been shown in some studies but not in a multicenter clinical trial. Our purpose was to evaluate the test-retest reliability of a proprietary CHD-DPBSPQ. Methods. The CHD-DPBSPQ uses a standard procedure for measuring symptoms. The (interrater) reliability and validity of this questionnaire have been previously studied. Here, we evaluated the test interval and weighted kappa value of items of test-retest (intrarater) reliability of the CHD-DPBSPQ. The test-retest reliability was evaluated by the intraclass correlation coefficient (ICC) for the total CHD-DPBSPQ score and the phlegm domain and blood stasis domain scores. Weighted kappa statistics were calculated for the individual CHD-DPBSPQ items. Results. Using the CHD-DPBSPQ, 79 patients with late-stage CHD who were participating in a multicenter clinical trial were assessed twice. The ICCs for the CHD-DPBSPQ score were as follows: 0.827 for the total CHD-DPBSPQ, 0.778 for the phlegm domain score, and 0.828 for the blood stasis domain score. The reliability was slightly better in patients whose test interval was ≤14 days. The weighted kappa values of individual items showed moderate consistency. Conclusions. The CHD-DPBSPQ was found to have excellent test-retest reliability in this sample of patients.

scholarly journals Characteristics of Obstructive Sleep Apnea Patients With Hypertension and Factors Associated With Autotitration Acceptance

2022 ◽  
Vol 12 ◽  
Author(s):  
Xuan Zhang ◽  
Ning Zhang ◽  
Yang Yang ◽  
Shuo Wang ◽  
Ping Yu ◽  
...  
Keyword(s):  
Obstructive Sleep Apnea ◽  
Sleep Apnea ◽  
Eye Movement ◽  
Total Sleep Time ◽  
Sleep Time ◽  
Sleep Efficiency ◽  
Apnea Hypopnea Index ◽  
Rapid Eye Movement ◽  
Obstructive Sleep ◽  
Severe Group

In order to explore the characteristics and treatment status of obstructive sleep apnea (OSA) patients with hypertension, a retrospective study was conducted on 306 patients admitted from October 2018 to December 2019. According to the apnea hypopnea index (AHI), OSA patients with hypertension were divided into three groups. 69 cases were mild OSA (5 ≤ AHI < 15), 86 cases were moderate (15 ≤ AHI < 30), and 151 cases were severe (AHI ≥ 30). Compared with patients in the mild and moderate groups, the severe group had more male patients, with higher body mass index (BMI) and non-rapid eye movement stage 1 accounted for total sleep time (N1%), and lower non-rapid eye movement stage 2 accounted for total sleep time (N2%), average and minimum blood oxygen. Among all the patients, those who underwent the titration test accounted for 20.6% (63/306). Multivariate analysis showed that sleep efficiency (p < 0.001) and AHI (p < 0.001) were independent factors for patients to accept titration test. OSA patients with hypertension had a low acceptance of titration therapy. These people with higher sleep efficiency and AHI were more likely to receive autotitration.

scholarly journals Sleep Efficiency and Total Sleep Time in Individuals with Type 2 Diabetes with and without Insomnia Symptoms

2020 ◽  
Vol 2020 ◽  
pp. 1-12
Author(s):  
Mohammed M. Alshehri ◽  
Abdulaziz A. Alkathiry ◽  
Aqeel M. Alenazi ◽  
Shaima A. Alothman ◽  
Jason L. Rucker ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Total Sleep Time ◽  
Sleep Time ◽  
Sleep Efficiency ◽  
Group Differences ◽  
Sleep Diaries ◽  
Symptoms Of Depression ◽  
Sleep Parameters ◽  
Insomnia Symptoms

There is increasing awareness of the high prevalence of insomnia symptoms in individuals with type 2 diabetes (T2D). Past studies have established the importance of measuring sleep parameters using measures of central tendency and variability. Additionally, subjective and objective methods involve different constructs due to the discrepancies between the two approaches. Therefore, this study is aimed at comparing the averages of sleep parameters in individuals with T2D with and without insomnia symptoms and comparing the variability of sleep parameters in these individuals. This study assessed the between-group differences in the averages and variability of sleep efficiency (SE) and total sleep time (TST) of 59 participants with T2D with and without insomnia symptoms. Actigraph measurements and sleep diaries were used to assess sleep parameter averages and variabilities calculated by the coefficient of variation across 7 nights. Mann–Whitney U tests were utilized to compare group differences in the outcomes. Validated instruments were used to assess the symptoms of depression, anxiety, and pain as covariates. Objective SE was found to be statistically lower on average (85.98±4.29) and highly variable (5.88±2.57) for patients with T2D and insomnia symptoms than in those with T2D only (90.23±6.44 and 3.82±2.05, respectively). The subjective average and variability of SE were also worse in patients with T2D and insomnia symptoms, with symptoms of depression, anxiety, and pain potentially playing a role in this difference. TST did not significantly differ between the groups on averages or in variability even after controlling for age and symptoms of depression, anxiety, and pain. Future studies are needed to investigate the underlying mechanisms of worse averages and variability of SE in individuals with T2D and insomnia symptoms. Additionally, prompting the associated risk factors of insomnia symptoms in individuals with T2D might be warranted.

The selective orexin-2 receptor antagonist seltorexant improves sleep: An exploratory double-blind, placebo controlled, crossover study in antidepressant-treated major depressive disorder patients with persistent insomnia

2019 ◽  
Vol 33 (2) ◽  
pp. 202-209 ◽  
Author(s):  
Sander Brooks ◽  
Gabriël E Jacobs ◽  
Peter de Boer ◽  
Justine M Kent ◽  
Luc Van Nueten ◽  
...  
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Depressive Symptomatology ◽  
Total Sleep Time ◽  
Sleep Time ◽  
Sleep Efficiency ◽  
Least Square ◽  
Self Report ◽  
Major Depressive ◽  
Double Blind

Background: Insomnia is common in patients with major depressive disorder. Although antidepressants improve mood, insomnia often persists as a result of physiological hyperarousal. The orexin-2 receptor is increasingly being recognized as a new target for the treatment of persistent insomnia in major depressive disorder . Aim: This exploratory study investigated the effects of seltorexant on objective sleep parameters and subjective depressive symptoms in antidepressant treated major depressive disorder patients with persistent insomnia. Methods: Twenty male and female patients received a single dose of 10, 20, 40 mg seltorexant and placebo with a washout period of seven days in a double-blind four-way crossover study. Effects on latency to persistent sleep, total sleep time and sleep efficiency were assessed with polysomnography. Subjective changes in mood were explored by the Quick Inventory of Depressive Symptomatology Self-Report. Safety was recorded and suicidal ideation and behavior were assessed with the Columbia Suicide Severity Rating Scale. Results: Latency to persistent sleep was significantly shorter for all doses of seltorexant compared to placebo. Placebo least square mean was 61.05 min with least square mean ratios treatment/placebo (80% confidence interval) of 0.32 (0.24–0.44), 0.15 (0.11–0.2) and 0.17 (0.12–0.23) 19.69, 9.2, 10.15 for 10, 20 and 40 mg seltorexant respectively, (all p<0.001). Total sleep time was significantly longer for all doses of seltorexant compared to placebo. Sleep efficiency was significantly improved. The Quick Inventory of Depressive Symptomatology Self-Report demonstrated a trend to mood-improvement for the 40 mg group. Conclusions: Seltorexant showed a statistically significant, dose-dependent decrease in latency to persistent sleep, and increase in total sleep time and sleep efficiency combined with a tendency toward subjectively improved mood.

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