How are normal sleeping controls selected? A systematic review of cross-sectional insomnia studies, and a standardised method to select healthy controls for sleep research

There appears to be some inconsistency in how normal sleepers (controls) are selected and screened for participation in research studies for comparison with insomnia patients. The purpose of the current study is to assess and compare methods of identifying normal sleepers in insomnia studies, with reference to published standards. We systematically reviewed the literature on insomnia patients which included control subjects. The resulting 37 articles were systematically reviewed with reference to the five criteria for normal sleep specified by Edinger et al. (2004). In summary, these criteria are: evidence of sleep disruption; sleep scheduling; general health; substance/medication use; and other sleep disorders. We found sleep diaries, PSG, and clinical screening examinations to be widely used with both control subjects and insomnia participants. However, there are differences between research groups in the precise definitions applied to the components of normal sleep. We found that none of reviewed studies applied all of the Edinger et al. criteria, and 16% met four criteria. In general, screening is applied most rigorously at the level of a clinical disorder, whether physical, psychiatric, or sleep. While the Edinger et al. criteria seem to be applied in some form by most researchers, there is scope to improve standards and definitions in this area. Ideally, different methods such as sleep diaries and questionnaires would be used concurrently with objective measures to ensure normal sleepers are identified, and descriptive information for control subjects would be reported. Here, we have devised working criteria and methods to be used for assessment of normal sleepers. This would help clarify the nature of the control group, in contrast to insomnia subjects and other patient groups

Social interactions, emotion and sleep: a systematic review and research agenda

Sleep and emotion are closely linked, however the effects of sleep on socio-emotional task performance have only recently been investigated. Sleep loss and insomnia have been found to affect emotional reactivity and social functioning, although results, taken together, are somewhat contradictory. Here we review this advancing literature, aiming to 1) systematically review the relevant literature on sleep and socio-emotional functioning, with reference to the extant literature on emotion and social interactions, 2) summarize results and outline ways in which emotion, social interactions, and sleep may interact, and 3) suggest key limitations and future directions for this field. From the reviewed literature, sleep deprivation is associated with diminished emotional expressivity and impaired emotion recognition, and this has particular relevance for social interactions. Sleep deprivation also increases emotional reactivity; results which are most apparent with neuro-imaging studies investigating amygdala activity and its prefrontal regulation. Evidence of emotional dysregulation in insomnia and poor sleep has also been reported. In general, limitations of this literature include how performance measures are linked to self-reports, and how results are linked to socio-emotional functioning. We conclude by suggesting some possible future directions for this field

The Sleep Condition Indicator: a clinical screening tool to evaluate insomnia disorder

Objective: Describe the development and psychometric validation of a brief scale (the Sleep Condition Indicator (SCI)) to evaluate insomnia disorder in everyday clinical practice.<p></p> Design: The SCI was evaluated across five study samples. Content validity, internal consistency and concurrent validity were investigated.<p></p> Participants: 30 941 individuals (71% female) completed the SCI along with other descriptive demographic and clinical information.<p></p> Setting: Data acquired on dedicated websites.<p></p> Results: The eight-item SCI (concerns about getting to sleep, remaining asleep, sleep quality, daytime personal functioning, daytime performance, duration of sleep problem, nights per week having a sleep problem and extent troubled by poor sleep) had robust internal consistency (α≥0.86) and showed convergent validity with the Pittsburgh Sleep Quality Index and Insomnia Severity Index. A two-item short-form (SCI-02: nights per week having a sleep problem, extent troubled by poor sleep), derived using linear regression modelling, correlated strongly with the SCI total score (r=0.90).<p></p> Conclusions: The SCI has potential as a clinical screening tool for appraising insomnia symptoms against Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.<p></p&gt

Executive functions in insomnia disorder: a systematic review and exploratory meta-analysis

Background: Executive functions (EFs) are involved in the control of basic psychological processes such as attention and memory and also contribute to emotion regulation. Research on the presence of EFs impairments in insomnia yielded inconsistent results. Therefore, we performed a systematic review of the literature on three EFs: inhibitory control, working memory, and cognitive flexibility in adults with insomnia in order to investigate the presence and magnitude of insomnia-related EFs impairments. Methods: PubMed, Scopus, Medline, and PsycINFO were searched. Risk of bias assessment of included studies was performed by two independent researchers. Findings were summarised using both a narrative approach and meta-analysis. Cohen’s d was calculated at 95% confidence interval (CI) as effect size of between groups differences. Results: Twenty-eight studies comparing adult individuals with a diagnosis of insomnia and healthy controls on neuropsychological measures of EFs were included. Narrative synthesis revealed substantial variability across study findings. Factors that were primarily hypothesised to account for this variability are: objective sleep impairments and test sensitivity. Exploratory meta-analysis showed impaired performance of small to moderate magnitude in individuals with insomnia as compared to controls in reaction times, but not accuracy rates, of inhibitory control (d = −0.32, 95% CI: −0.52 to −0.13) and cognitive flexibility tasks (d = −0.30, 95% CI: −0.59 to −0.01). Performance in working memory tasks was also significantly impacted (d = −0.19, 95% CI: −0.38 to −0.00). Effects sizes were larger when insomnia was associated with objective sleep impairments, rather than normal sleep. Conclusions: We gathered evidence supporting small to moderate deficits in EFs in individuals with insomnia. Due to the small sample size results should be considered preliminary and interpreted carefully

Further discussion of a preliminary study of sleep quality in functional neurological disorders : a reply to Professor Kawada

We would like to thank Prof. Kawada for his interest in our manuscript (1), which describes a preliminary investigation of sleep quality in people with functional neurological disorders (FND). Below we respond to Prof. Kawada's comments

Heart rate variability in insomnia patients: A critical review of the literature

Heart rate variability (HRV) is an objective marker that provides insight into autonomic nervous system dynamics. There is conflicting evidence regarding the presence of HRV impairment in insomnia patients. Web-based databases were used to systematically search the literature for all studies that compared the HRV of insomnia patients to controls or reported the HRV of insomnia patients before and after an intervention. 22 relevant papers were identified. Study characteristics were summarised, HRV measures were extracted and a risk of bias assessment for each study was performed. We were limited in our ability to synthesise outcome measures and perform meta-analyses due to considerable differences in patient (and control) selection, study protocols, measurement and processing techniques and outcome reporting. Risk of bias was deemed to be high in the majority of studies. As such, we cannot confirm that HRV is reliably impaired in insomnia patients nor determine the HRV response to interventions. Whilst HRV impairment in insomnia is a widely accepted concept, it is not supported by empirical evidence. Large longitudinal studies incorporating 24-hour recordings are required to elucidate the precise nature of HRV dynamics in insomnia patients

Insomnia prehabilitation in newly diagnosed breast cancer patients: Protocol for a pilot, multicentre, randomised controlled trial comparing nurse delivered sleep restriction therapy to sleep hygiene education (INVEST trial)

Introduction: Insomnia is a prevalent sleep disorder that negatively impacts daytime functioning and quality of life. Breast cancer patients report higher rates of insomnia and more circadian disruption than other cancer groups. Approximately 50% of patients experience acute insomnia following breast cancer diagnosis, which often persists during cancer treatment and rehabilitation. Sleep Restriction Therapy (SRT) is a clinically effective and tolerable treatment for persistent insomnia in breast cancer survivors. However, SRT has never been tested on patients with early signs of sleep disturbance who are undergoing cancer treatment. The aim of this pilot randomised controlled trial is to explore the feasibility and preliminary effectiveness of nurse delivered SRT for newly diagnosed breast cancer patients with acute insomnia. The trial has been registered on ClinicalTrials.gov (identifier: NCT06294041). Methods: The INVEST (INvestigating the Value of Early Sleep Therapy) trial will recruit 50 newly diagnosed breast cancer patients who meet criteria for acute insomnia. Patients will be recruited from breast cancer results clinics within two Scottish health boards (NHS Grampian and NHS Greater Glasgow and Clyde) and will be block randomised (1:1) to receive nurse delivered SRT or Sleep Hygiene Education (SHE). SRT will be delivered over 4 weekly sessions comprising two face-to-face meetings (either in person or online) and two telephone calls, whereas SHE will be administered in booklet form. Outcomes will be collected at baseline, 6 weeks, and 12 weeks post-randomisation. Primary outcomes in this trial relate to the feasibility of SRT for newly diagnosed breast cancer patients with acute insomnia. Specifically, we will explore (i) rates of patient recruitment and retention, (ii) intervention fidelity, (iii) data collection procedures and outcome measure completion, (iv) intervention acceptability. Secondary outcomes will focus on preliminary evaluation of patient responses to SRT, including insomnia severity, rest-activity rhythms, and mental health. Dissemination: Our dissemination plan comprises publishing trial outcomes in high-impact, peer-reviewed journals and on breast cancer charity websites and other patient resources. The outcomes from this pilot trial will also inform the development of a full-scale, multicentre RCT of SRT for acute insomnia in newly diagnosed breast cancer patients. University of Strathclyde is the sponsor (reference: UEC23/52). Protocol version v1.2 4 October 2023. Strengths and limitations of this study: This trial is the first to explore the value of sleep prehabilitation for newly diagnosed breast cancer patients. This will be the first trial to assess the feasibility of delivering SRT during breast cancer treatment, providing valuable insight into its tolerability and preliminary effectiveness. An embedded process evaluation will assess the acceptability of SRT, providing insight into potential optimisation of the intervention and recommendations for enhancing its future scalability and translation within cancer care. Due to the nature of the SRT intervention, nurse therapists and patients cannot be blinded to treatment allocation, increasing the risk of bias

Attention to beds in natural scenes by observers with insomnia symptoms

Attention biases to sleep-related stimuli are held to play a key role in the development and maintenance of insomnia, but such biases have only been shown with controlled visual displays. This study investigated whether observers with insomnia symptoms allocate attention to sleep-related items in natural scenes, by recording eye movements during free-viewing of bedrooms. Participants with insomnia symptoms and normal sleepers were matched in their visual exploration of these scenes, and there was no evidence that the attention of those with insomnia symptoms was captured more quickly by sleep-related stimuli than that of normal sleepers. However, the insomnia group fixated bed regions on more trials and, once fixated on a bed, also remained there for longer. These findings indicate that sleep stimuli are particularly effective in retaining visual attention in complex natural scenes

How are normal sleeping controls selected? A systematic review of cross-sectional insomnia studies, and a standardised method to select healthy controls for sleep research

There appears to be some inconsistency in how normal sleepers (controls) are selected and screened for participation in research studies for comparison with insomnia patients. The purpose of the current study is to assess and compare methods of identifying normal sleepers in insomnia studies, with reference to published standards. We systematically reviewed the literature on insomnia patients which included control subjects. The resulting 37 articles were systematically reviewed with reference to the five criteria for normal sleep specified by Edinger et al. (2004). In summary, these criteria are: evidence of sleep disruption; sleep scheduling; general health; substance/medication use; and other sleep disorders. We found sleep diaries, PSG, and clinical screening examinations to be widely used with both control subjects and insomnia participants. However, there are differences between research groups in the precise definitions applied to the components of normal sleep. We found that none of reviewed studies applied all of the Edinger et al. criteria, and 16% met four criteria. In general, screening is applied most rigorously at the level of a clinical disorder, whether physical, psychiatric, or sleep. While the Edinger et al. criteria seem to be applied in some form by most researchers, there is scope to improve standards and definitions in this area. Ideally, different methods such as sleep diaries and questionnaires would be used concurrently with objective measures to ensure normal sleepers are identified, and descriptive information for control subjects would be reported. Here, we have devised working criteria and methods to be used for assessment of normal sleepers. This would help clarify the nature of the control group, in contrast to insomnia subjects and other patient groups