BACKGROUND Cognitive behavioral therapy for insomnia (CBTi) is the first-line therapy for chronic insomnia. Mobile app–based CBTi (MCBTi) can enhance the accessibility of CBTi treatment; however, few studies have evaluated the effectiveness of MCBTi using a multicenter, randomized controlled trial design. OBJECTIVE We aimed to assess the efficacy of Somzz, an MCBTi that provides real-time and tailored feedback to users, through comparison with an active comparator app. METHODS In our multicenter, single-blind randomized controlled trial study, participants were recruited from 3 university hospitals and randomized into a Somzz group and a sleep hygiene education (SHE) group at a 1:1 ratio. The intervention included 6 sessions for 6 weeks, with follow-up visits over a 4-month period. The Somzz group received audiovisual sleep education, guidance on relaxation therapy, and real-time feedback on sleep behavior. The primary outcome was the Insomnia Severity Index score, and secondary outcomes included sleep diary measures and mental health self-reports. We analyzed the outcomes based on the intention-to-treat principle. RESULTS A total of 98 participants were randomized into the Somzz (n=49, 50%) and SHE (n=49, 50%) groups. Insomnia Severity Index scores for the Somzz group were significantly lower at the postintervention time point (9.0 vs 12.8; t<sub>95</sub>=3.85; <i>F</i><sub>2,95</sub>=22.76; η<sub>p</sub><sup>2</sup>=0.13; <i>P</i><.001) and at the 3-month follow-up visit (11.3 vs 14.7; t<sub>68</sub>=2.61; <i>F</i><sub>2,68</sub>=5.85; η<sub>p</sub><sup>2</sup>=0.03; <i>P</i>=.01) compared to those of the SHE group. The Somzz group maintained their treatment effect at the postintervention time point and follow-ups, with a moderate to large effect size (Cohen <i>d</i>=–0.62 to –1.35; <i>P</i><.01 in all cases). Furthermore, the Somzz group showed better sleep efficiency (t<sub>95</sub>=–3.32; <i>F</i><sub>2,91</sub>=69.87; η<sub>p</sub><sup>2</sup>=0.41; <i>P</i>=.001), wake after sleep onset (t<sub>95</sub>=2.55; <i>F</i><sub>2,91</sub>=51.81; η<sub>p</sub><sup>2</sup>=0.36; <i>P</i>=.01), satisfaction (t<sub>95</sub>=–2.05; <i>F</i><sub>2,91</sub>=26.63; η<sub>p</sub><sup>2</sup>=0.20; <i>P</i>=.04) related to sleep, and mental health outcomes, including depression (t<sub>95</sub>=2.11; <i>F</i><sub>2,94</sub>=29.64; η<sub>p</sub><sup>2</sup>=0.21; <i>P</i>=.04) and quality of life (t<sub>95</sub>=–3.13; <i>F</i><sub>2,94</sub>=54.20; η<sub>p</sub><sup>2</sup>=0.33; <i>P</i>=.002), compared to the SHE group after the intervention. The attrition rate in the Somzz group was 12% (6/49). CONCLUSIONS Somzz outperformed SHE in improving insomnia, mental health, and quality of life. The MCBTi can be a highly accessible, time-efficient, and effective treatment option for chronic insomnia, with high compliance. CLINICALTRIAL Clinical Research Information Service (CRiS) KCT0007292; https://cris.nih.go.kr/cris/search/detailSearch.do?seq=22214&search_page=L
Background: Mood disorders require consistent management of symptoms to prevent recurrences of mood episodes. Circadian rhythm disruption is a key symptom of mood disorders to be proactively managed to prevent mood recurrences. This study aims to predict impending mood episodes recurrences using digital phenotypes related to circadian rhythm obtained from wearable devices and smartphones.Methods: The study is a multicenter, nationwide, prospective, observational study of young adults diagnosed with major depressive disorder (MDD), bipolar disorder I (BD I), and bipolar II disorder (BD II). A total of 495 patients were recruited from eight hospitals in South Korea. Patients were followed up for an average of 279.7 days (a total sample of 75,506 days) with wearable devices and smartphones and with clinical interviews conducted every three months. Algorithms predicting impending mood episodes were developed with machine learning. Algorithm-predicted mood episodes were then compared to those identified through face-to-face clinical interviews incorporating ecological momentary assessments of daily mood and energy.Outcomes: 270 mood episodes recurred in 135 subjects during the follow-up period. The prediction accuracies for impending major depressive episodes, manic episodes, and hypomanic episodes for the next three days were 90.1%, 92.6%, and 93.0%, with the area under the curve values of 0.937, 0.957, and 0.963, respectively.Interpretation: We predicted the onset of mood episode recurrences exclusively using digital phenotypes. Specifically, phenotypes indicating circadian rhythm misalignment contributed the most to the prediction of episodes recurrences. Our findings suggest that monitoring of circadian rhythm using digital devices can be useful in preventing and treating mood disorders.Funding Information: The Ministry of Health & Welfare, Republic of Korea; the National Research Foundation of Korea.Declaration of Interests: HJL is supported by grant number HM14C2606 from the Ministry of Health & Welfare and grant number 2017M3A9F1031220/2019R1A2C2084158 from the National Research Foundation of Korea. LK and HJL are co-founders and shareholders of Hucircadian. The other authors have no conflicts of interest to disclose.Ethics Approval Statement: The study was approved by the Institutional Review Boards of all participating hospitals and conducted in accordance with the Declaration of Helsinki. All participants provided written informed consents before enrollment after receiving full explanations of the study.
BACKGROUND Insomnia is a prevalent sleep disorder affecting millions worldwide, with significant impacts on daily functioning and quality of life. While traditionally assessed through subjective measures such as the Insomnia Severity Index (ISI), the advent of wearable technology has enabled continuous, objective sleep monitoring in natural environments. However, the relationship between subjective insomnia severity and objective sleep parameters remains unclear. OBJECTIVE This study aims to (1) explore the relationship between subjective insomnia severity, as measured by ISI scores, and activity-based objective sleep parameters obtained through wearable devices; (2) determine whether subjective perceptions of insomnia align with objective measures of sleep; and (3) identify key psychological and physiological factors contributing to the severity of subjective insomnia complaints. METHODS A total of 250 participants, including both individuals with and without insomnia aged 19-70 years, were recruited from March 2023 to November 2023. Participants were grouped based on ISI scores: no insomnia, mild, moderate, and severe insomnia. Data collection involved subjective assessments through self-reported questionnaires and objective measurements using wearable devices (Fitbit Inspire 3) that monitored sleep parameters, physical activity, and heart rate. The participants also used a smartphone app for ecological momentary assessment, recording daily alcohol consumption, caffeine intake, exercise, and stress. Statistical analyses were used to compare groups on subjective and objective measures. RESULTS Results indicated no significant differences in general sleep structure (eg, total sleep time, rapid eye movement sleep time, and light sleep time) among the insomnia groups (mild, moderate, and severe) as classified by ISI scores (all <i>P</i>>.05). Interestingly, the no insomnia group had longer total awake times and lower sleep quality compared with the insomnia groups. Among the insomnia groups, no significant differences were observed regarding sleep structure (all <i>P</i>>.05), suggesting similar sleep patterns regardless of subjective insomnia severity. There were significant differences among the insomnia groups in stress levels, dysfunctional beliefs about sleep, and symptoms of restless leg syndrome (all <i>P</i>≤.001), with higher severity associated with higher scores in these factors. Contrary to expectations, no significant differences were observed in caffeine intake (<i>P</i>=.42) and alcohol consumption (<i>P</i>=.07) between the groups. CONCLUSIONS The findings demonstrate a discrepancy between subjective perceptions of insomnia severity and activity-based objective sleep parameters, suggesting that factors beyond sleep duration and quality may contribute to subjective sleep complaints. Psychological factors, such as stress, dysfunctional sleep beliefs, and symptoms of restless legs syndrome, appear to play significant roles in the perception of insomnia severity. These results highlight the importance of considering both subjective and objective assessments in the evaluation and treatment of insomnia and suggest potential avenues for personalized treatment strategies that address both psychological and physiological aspects of sleep disturbances. CLINICALTRIAL Clinical Research Information Service KCT0009175; https://cris.nih.go.kr/cris/search/detailSearch.do?seq=26133
Background Insomnia is a prevalent sleep disorder affecting millions worldwide, with significant impacts on daily functioning and quality of life. While traditionally assessed through subjective measures such as the Insomnia Severity Index (ISI), the advent of wearable technology has enabled continuous, objective sleep monitoring in natural environments. However, the relationship between subjective insomnia severity and objective sleep parameters remains unclear. Objective This study aims to (1) explore the relationship between subjective insomnia severity, as measured by ISI scores, and activity-based objective sleep parameters obtained through wearable devices; (2) determine whether subjective perceptions of insomnia align with objective measures of sleep; and (3) identify key psychological and physiological factors contributing to the severity of subjective insomnia complaints. Methods A total of 250 participants, including both individuals with and without insomnia aged 19-70 years, were recruited from March 2023 to November 2023. Participants were grouped based on ISI scores: no insomnia, mild, moderate, and severe insomnia. Data collection involved subjective assessments through self-reported questionnaires and objective measurements using wearable devices (Fitbit Inspire 3) that monitored sleep parameters, physical activity, and heart rate. The participants also used a smartphone app for ecological momentary assessment, recording daily alcohol consumption, caffeine intake, exercise, and stress. Statistical analyses were used to compare groups on subjective and objective measures. Results Results indicated no significant differences in general sleep structure (eg, total sleep time, rapid eye movement sleep time, and light sleep time) among the insomnia groups (mild, moderate, and severe) as classified by ISI scores (all P>.05). Interestingly, the no insomnia group had longer total awake times and lower sleep quality compared with the insomnia groups. Among the insomnia groups, no significant differences were observed regarding sleep structure (all P>.05), suggesting similar sleep patterns regardless of subjective insomnia severity. There were significant differences among the insomnia groups in stress levels, dysfunctional beliefs about sleep, and symptoms of restless leg syndrome (all P≤.001), with higher severity associated with higher scores in these factors. Contrary to expectations, no significant differences were observed in caffeine intake (P=.42) and alcohol consumption (P=.07) between the groups. Conclusions The findings demonstrate a discrepancy between subjective perceptions of insomnia severity and activity-based objective sleep parameters, suggesting that factors beyond sleep duration and quality may contribute to subjective sleep complaints. Psychological factors, such as stress, dysfunctional sleep beliefs, and symptoms of restless legs syndrome, appear to play significant roles in the perception of insomnia severity. These results highlight the importance of considering both subjective and objective assessments in the evaluation and treatment of insomnia and suggest potential avenues for personalized treatment strategies that address both psychological and physiological aspects of sleep disturbances. Trial Registration Clinical Research Information Service KCT0009175; https://cris.nih.go.kr/cris/search/detailSearch.do?seq=26133
Evidence for the association between circadian rhythm delay and depression is accumulating. Genetic studies have shown that certain polymorphisms in circadian genes are potential genetic markers of diurnal preference. Along with circadian genes, there is a growing interest in other genetic effects on circadian rhythms. This study evaluated whether the HTR2A rs6311 (-1438C/T) polymorphism is associated with diurnal preference in a Korean population.A total of 510 healthy subjects were included in this study. All subjects were genotyped for the HTR2A rs6311 polymorphism and they completed the Korean version of the composite scale of morningness (CSM).The C allele carriers (C/C+C/T) showed significantly higher CSM scores compared to C allele non-carriers (T/T) (t=2.22, p= 0.03), suggesting the existence of a morning chronotype tendency in C allele carriers. In other words, the T/T genotype may be associated with the evening chronotype.These results suggest that the HTR2A rs6311 polymorphism may be associated with diurnal preference in a healthy Korean population. The absence of the C allele may be responsible for the increasing susceptibility to eveningness in the Korean population. Further studies on HTR2A polymorphisms that evaluate their interactions with various candidate genes and differences in phenotypic expression of polymorphisms according to ethnic groups are warranted to fully understand their association with diurnal preference.
To investigate the impact of circadian rhythm disruptions on mental health among college students and explore effective interventions for maintaining stable circadian rhythms.
Objective Herbal and natural supplements have gained popularity as alternative treatments to insomnia and sleep disorders due to their perceived safety and potential effectiveness. This literature review summarizes the current evidence on the efficacy, safety, and mechanisms of action of commonly used supplements for sleep, including valerian, hops, kava, German chamomile, cherry, tryptophan, theanine, melatonin, magnesium, and zinc.Methods We conducted literature review of clinical research on herbal and supplements for sleep reported to date. We summarized key findings and reviewed outcomes related to clinical efficacy and side effects.Results Findings suggest that certain supplements, particularly valerian, hops, and melatonin, could be effective in improving sleep quality and reducing insomnia symptoms through modulation of neurotransmitter systems and regulation of sleep-wake cycles. However, the strength of the evidence varies with unestablished optimal dosages, formulations, and treatment durations. Although generally considered safe, these supplements are not without risks, such as rare but serious adverse effects associated with kava and potential interactions with prescription medications. The quality and purity of supplements also vary widely due to a lack of strict regulations.Conclusion Healthcare providers should remain informed about the latest research and work closely with patients to develop personalized treatment plans. Herbal and natural supplements may offer promising alternatives or adjunct treatments for insomnia and sleep disorders, but their use should be guided by the best available evidence and individual patient requirements. Larger, well-designed clinical trials are needed to establish the efficacy and safety of these supplements for clinical decision-making.
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