Effect of Tomato (Solanum lycopersicum) Extract in Patients with Primary Insomnia: A Double-blind Randomized Study.

OBJECTIVE: Insomnia is a condition that causes sleep problems, and many people suffer from it. Patients with this disorder have difficulty with beginning or continuation of sleep, so they are exhausted all day long, and their performance reduces. This study was designed to assess the efficacy of capsules that contain tomato extract in patients with primary insomnia. METHODS: In this study, 70 patients with primary insomnia were assigned to 2 groups randomly: intervention and control. The intervention group used to take tomato capsules every night for 2 weeks, and the placebo one used to take placebo capsules every night for 2 weeks. All patients used to fill out Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI) questionnaires before and after the intervention. ISI and PSQI results were analyzed separately on SPSS software. RESULTS: A total of 70 patients (35 in the intervention group and 35 in the control group), including 50 females and 20 males, were studied. Female to male ratio and the rate of unemployment were significantly higher in the intervention group (in both cases P < 0.001), but there was no significant difference between the intervention and control groups in other characteristics (Age, marital status, weight, height, education; in all cases P > 0.05). At the end of the study, the amount of actual sleep had increased, and the delay in falling asleep decreased in both groups; the two groups at the end of the study were not significantly different in terms of these two variables (P > 0.05). The ISI score in both groups decreased significantly at the end of the study, and the PSQI score in both groups decreased significantly at the end of the study (In both cases, P < 0.05). The absolute value of ISI score change in the intervention group was significantly higher than the control group (P < 0.001); But the absolute value of PSQI score change was not significantly different between the two groups (P = 0.102). Most importantly, the improvement of both ISI and PSQI scores in the intervention group was significantly better than the control group (P > 0.05). CONCLUSION: This study showed that tomato capsules have sleep-inducing effects, although there was no significant difference in the amount of actual sleep, and the delay in falling sleep in the intervention group compared to the control group.

The effect of oral capsule of Ocimum basilicum leaf extract on sleep quality and insomnia severity in menopausal women: A randomized clinical trial.

One of the complications of menopause is sleep disorders, which affect women's health. Ocimum basilicum contains compounds that may affect sleep. The aim of this study was to determine the effect of an oral capsule of O. basilicum leaf extract on sleep quality and the severity of insomnia in menopausal women. This triple-blind, randomized clinical trial study was performed on 60 Iranian menopausal women aged 40 to 65 years. Subjects were randomly assigned into two groups of intervention (each capsule containing 250 mg of O. basilicum extract and 250 mg Avicel) per day for 1 month and placebo. The Pittsburgh Sleep Quality and Insomnia Intensity Index were used to assess sleep quality and severity of insomnia before, 2 weeks after and 1 month after the intervention. There was no statistically significant difference in the baseline variables between the intervention and placebo groups (p > .05). The total sleep quality scores in the two groups of intervention and placebo were 6.2 ± 0.3 versus 9.3 ± 0.3 (p < .001) and 3.7 ± 0.3 versus 9.1 ± 0.3 (p = .015) 2 weeks and 1 month after the intervention, respectively. The total insomnia severity scores in the two groups of intervention and placebo were 9.0 ± 0.3 versus 12.1 ± 0.3 (p < .001) and 5.6 ± 0.5 versus 11.0 ± 0.5 (p < .001) 2 weeks and 1 month after the intervention, respectively. Consumption of O. basilicum capsules improved sleep quality and insomnia in menopausal women. This study was approved (code IR.MUMS.NURSE.REC.1398.070) by the Ethic committee of Mashhad University of Medical Sciences and registered at the Iranian Registry of Clinical Trials, with the No. IRCT20200104046001N1 in January 2020.

A Survey on Sleep Disorders and Related Hormones in Patients with Newly Diagnosed Systemic Lupus Erythematosus.

BACKGROUND AND OBJECTIVES: Systemic lupus erythematosus (SLE) is reportedly associated with sleep disorders. Thus, the present study aimed to investigate sleep disorders in newly diagnosed SLE patients. MATERIALS AND METHODS: This study was conducted on patients with newly diagnosed SLE (ie, case group) and a control group. The case and control groups were matched in terms of gender, age, socioeconomic status, and educational level. Venous blood samples were obtained from the participants to measure prolactin and melatonin levels. Furthermore, they were subjected to polysomnography. The data were analysed by SPSS (version 16) at a significance level of 0.05. RESULTS: A total of 28 women were enrolled in this study (ie, 14 individuals in each group). The frequencies of sleep disorder in the case and control groups were obtained as 64.3% and 50%, respectively (P=0.4). These two groups had the mean sleep onset times of 10.76±10.64 and 8.67±7.12 min (P=0.5) and the respiratory disturbance indices of 9.20±10.23 and 8.44±9.27, respectively (P=0.8). The frequency of sleep apnoea was obtained at 50% for both case and control groups (P=1). There was no significant difference between these groups in terms of the mean serum prolactin and melatonin levels (P=0.3 and P=0.2, respectively). Serum melatonin level showed a direct correlation with sleep latency to N1 (i.e., the first part of non-rapid eye movement in sleep) and spontaneous arousal index in the case group (P=0.02, r=0.602 and P=0.04, r=0.544, respectively). CONCLUSION: According to the findings, there was no significant difference in the frequency of sleep disorders between the healthy subjects and patients at the onset of lupus. Additionally, melatonin and prolactin levels showed no significant difference between the groups. Our results are inconsistent with previous studies, due to the difference in disease duration probably. It seems that the chronicity and complications of the disease, as well as the adoption of glucocorticoid therapy for the chronic disease affect sleep quality in SLE patients more than disease duration.

Evaluating the effect of an educational intervention on the adherence rate to sleep study: A multi-centered stratified randomized controlled trial.

An appropriate diagnosis and effective treatment of sleep apnea can improve the associated quality of care and reduce morbidities. The study aims to develop and evaluate an educational intervention tailored to patients' needs in order to increase the rate of patients' adherence to physician's prescription for a sleep test. A multi-center, stratified, 2 parallel-arm, randomized controlled trial was conducted. The patients in the intervention group received the educational booklets on sleep apnea and sleep test which was designed based on the extracted factors through an in-depth interview with patients. All participants were contacted after two months to ask whether they completed an assessment for OSA. A total number of 1,650 individuals were screened. Finally, 104 participants were randomized to the control group (n = 50) or intervention group (n = 45) that did not differ significantly in baseline characteristics. The results of the intention to treat analysis indicate that patients in the intervention group were significantly more adherent to attend a sleep assessment for their OSA risk (30%; n = 15/50) than the patients in the control group (11.1%; n = 5/45, P <0.05). Age, history of diabetes, and the educational intervention were effective in performing the sleep test. Time limitations, Condition improvement, and high cost of diagnostic test were the most barriers, respectively. The intervention was successful in improving the adherence rate of patients to prescribed sleep test. However, the adherence rate to sleep study testing is still far from desirable and requires more complex interventions.

Adherence to prescribed overnight sleep study in patients suspected of sleep apnea: problem size and influential factors.

PURPOSE: Despite the serious consequences of sleep apnea, some patients do not follow their physicians' advice to undergo a sleep study. The present study aimed to determine the rate of adherence and influencing factors in conducting a polysomnography test in patients suspected of obstructive sleep apnea. METHODS: This qualitative and quantitative analysis was conducted between July 2017 and November 2019 on patients suspected of sleep apnea. The quantitative analysis aimed at determining the rate of adherence through a retrospective cross-sectional study. The qualitative content analysis was conducted on purposefully selected subgroup of patients suspected of obstructive sleep apnea who were referred for polysomnography. The required data were collected through the semi-structured in-depth interviews and then recorded, transcribed, and analyzed using SPSS.22 and MAXQDA10. RESULTS: Quantitative part: Of 311 patients (mean age: 47.6 ± 13.1 years) referred for polysomnography, 283 patients (91%) were at a high risk of developing obstructive sleep apnea. Among those referred for polysomnography, 31% (n = 95) adhered to recommendations for a sleep study. Qualitative part: Factors affecting adherence to polysomnography were categorized as "barriers" and "triggers." Barriers included inadequate knowledge, psychological factors, cost, and the service system. Triggers included adequate knowledge and tangible experience of consequences of the illness. CONCLUSION: The majority of patients at risk of developing obstructive sleep apnea did not follow the recommendation for polysomnography, indicating a need for systematic interventions. Among the identified barriers, knowledge and psychological factors are modifiable ones that can be addressed with the patient. We theorize that raising awareness among patients by providing additional information and eliminating concerns may help to increase the rate of adherence. Insurance coverage or subsidy to reduce the sleep study costs may also be an effective strategy to increase adherence to recommendations for polysomnography.

Factors Affecting Patients' Adherence to Continuous Positive Airway Pressure Therapy for Obstructive Sleep Apnea Disorder: A Multi-Method Approach.

BACKGROUND: Continuous positive airway pressure (CPAP) is the gold standard therapy for treating obstructive sleep apnea (OSA) disorder. However, patients' adherence to its regular use is poor. The present study aimed to determine the adherence rate to CPAP therapy by identifying factors affecting its regular use and its associated problems and discomforts among a sample population in Mashhad (Iran). METHODS: The study was conducted from October 2017 to March 2018 in Mashhad (Iran) using both quantitative and qualitative methods. The quantitative study was carried out using a retrospective cross-sectional data collection from five sleep clinics and one CPAP sales office. The patients were classified into an adherent and a non-adherent group to determine the factors affecting CPAP adherence. Quantitative data were analyzed using SPSS software (version 22.0). Additionally, a prospective qualitative study was performed through a series of telephone interviews using the content analysis method. Qualitative data were analyzed using MAXQDA 10 software. RESULTS: In the quantitative study, the medical records of 159 patients were used, out of which 79 (49.6%) were non-adherent to CPAP therapy. The mean age of all patients was 56.9±9.8 years. The mean body mass index, apnea-hypopnea index, and Epworth sleepiness scale (ESS) scores were 30.9±6.6 kg/m2, 37.2±28.1 events/hour, and 10.4±5.5, respectively. At baseline, the adherent group had a significantly higher age (P=0.006), higher oxygen desaturation index (P=0.006), and lower ESS (P=0.023) compared to the non-adherent group. In the qualitative study, a total of 29 telephone interviews were held with patients from the non-adherent group (8 women and 21 men). Analysis of the interviews resulted in three main categories (level of knowledge, discomfort, and costs) and nine sub-categories. CONCLUSION: A high percentage of OSA patients had poor adherence to CPAP therapy. Device-related issues could be adequately resolved by providing complementary information during follow-up visits. Moreover, efforts to reduce costs through comprehensive insurance coverage or with government subsidy would improve patients' adherence to CPAP therapy.

Prolonged Sleep Apnea in Two Patients with a History of Opium Abuse -A Case Report.

INTRODUCTION: Obstructive sleep apnea (OSA) is a highly prevalent sleep-disordered breathing (SDB). CASE REPORT: Two 53- and 51-year-old male cases with daytime sleepiness and opium abuse and severe sleep apnea and long respiratory events duration (200 and 275 seconds respectively) noted in polysomnography were reported at Ebn-e-Sina and Razavi hospitals, in Mashhad, Iran. After positive airway pressure (PAP) therapy respiratory events resolved and patients' daytime alertness improved. CONCLUSION: The long duration of sleep apnea could be the result of opium abuse. Therefore, drug history should be carefully considered in the evaluation of SDB patients. The PAP device was effective in the management of sleep respiratory events and the improvement of patient's complications.

Sleep quality after endoscopic sinus surgery in patients with sinonasal polyposis.

OBJECTIVES: Evaluate the effect of functional endoscopic sinus surgery (FESS) for nasal polyposis on sleep efficiency and polysomnographic parameters. SUBJECTS AND METHODS: This clinical trial was conducted on 15 patients with bilateral massive sinonasal polyposis who underwent FESS between August 2012 and September 2013. All participants were evaluated subjectively by employing the Pittsburgh Sleep Quality Index (PSQI) questionnaire and objectively (provided by polysomnographic parameters) before and 2 months after surgery. RESULTS: The evaluation of subjective criteria of sleep quality assessed by PSQI showed significant improvement, particularly in nocturnal awakening (P = 0.002). However, Apnea Hypopnea Index (AHI) was not reduced significantly after surgery (P = 0.233). Among patients who had suffered from obstructive sleep apnea, AHI was improved in 7 patients, deteriorated in 3 patients, and did not change in 1 patient. Although the mean duration of REM sleep stage increased from 15.2 ± 10.7 to 18.9 ± 7.9, this change was not statistically significant. Furthermore, arousal index decreased dramatically from 31.6 to 17.1 (P = 0.02) and sleep efficiency index was improved after the surgery (P = 0.008). CONCLUSIONS: This study documented the effect of resuming nasal cavity patency on improvement of sleep efficiency after FESS. In spite of insignificant effect of FESS on apnea index, alteration of other sleep parameters like arousal index following surgery may have a positive effect on sleep quality.

Drug Induced Sleep Endoscopy in Obstructive Sleep Apnea.

BACKGROUND: One of the main challenges of surgical treatment in Obstructive Sleep Apnea (OSA) is identifying the correct site of upper airway obstruction in an individual patient. Drug-Induced Sleep Endoscopy (DISE) in sedated patients with obstructive sleep apnea is the technique of choice for revealing anatomic and dynamic collapsible areas. MATERIALS AND METHODS: In a prospective cross-sectional study adult patients with OSA documented by polysomnography were evaluated by sleep endoscopy. DISE had been done by an otolaryngologist in the setting of operating room during infusion of propofol and after the start of snoring. Endoscopic findings were recorded and evaluated from the aspect of obstruction level, severity, and multiplicity. RESULTS: Twenty OSA patients (60% men) with mean±SD age of 38.9±9.26 years and mean Body Mass Index (BMI) of 26.57 kg/m2 were included in the study. OSA was severe in 11(55%) and moderate in 5(25%) subjects. Unilevel airway collapse was observed as retropalatal in 4(20%) and retrolingual in 3(15%) subjects. Multilevel collapse had been observed in the other 13(65%) patients. Most patients (65%) had multilevel obstruction especially those with BMI>30 (p<0.05). With increasing BMI, obstruction changed from unilevel to multilevel. None of the subjects showed complications with propofol or endoscopy procedure. CONCLUSION: Our study showed DISE is safe, easy to perform, and informative in OSA patients. In particular, we observed a significant association between obesity and multilevel upper airway collapse.

The correlation of anxiety and depression with obstructive sleep apnea syndrome.

BACKGROUND: Obstructive sleep apnea syndrome (OSAS) is a common sleep disorder characterized by repeated upper airway obstruction during sleep. While respiratory pauses followed by loud snoring and daytime sleepiness are the main symptoms of OSAS, the patients may complain from sleep disruption, headache, mood disturbance, irritability, and memory impairment. However, the association of sleep apnea with anxiety and depression is not completely understood. Adherence to continuous positive airway pressure (CPAP), the treatment of choice for OSAS, may be influenced by psychological conditions, especially claustrophobia. The aim of this study was to evaluate the association of OSAS with anxiety and depression symptoms. This study also investigated the association of anxiety with body mass index (BMI) and the severity of OSAS. MATERIALS AND METHODS: We conducted a cross-sectional study on 178 adult individuals diagnosed with OSAS at the sleep laboratory between September 2008 and May 2012. The participants were interviewed according to a checklist regarding both their chief complaints and other associated symptoms. The psychological status was assessed according to Beck anxiety inventory (BAI) and Beck depression inventory (BDI) scoring. The severity of breathing disorder was classified as mild, moderate, and severe based on apnea-hypopnea index (AHI) which was ascertained by overnight polysomnography. Daytime sleepiness was assessed by Epworth sleepiness scale (ESS). RESULTS: The mean (SD) age of participants was 50.33 years. In terms of sex, 85.5% of the study population were males and14.4% were females. We found no relation between sex and the symptoms of OSAS. Regarding the frequency of anxiety and depression symptoms, 53.9% of the individuals had some degree of anxiety, while 46.1% demonstrated depressive symptoms. In terms of OSAS severity, this study showed that OSAS severity was associated with the frequency of anxiety, chocking, and sleepiness (P : 0.001). According to polysomnographic results, we found that the majority of patients suffering from anxiety and chocking (66.7% and 71.4%, respectively) had severe OSAS, while only 23.1% of patients with sleepiness had severe OSAS. CONCLUSION: Our study showed that the frequency of anxiety in OSAS patients is higher than in the general population regardless of the gender. Furthermore, it is more likely that OSAS patients present with anxiety and depression than the typical symptoms.

The efficacy of gabapentin versus stabilization splint in management of sleep bruxism.

PURPOSE: This study aimed to determine if the use of gabapentin is more efficacious than a stabilization splint with regard to the intensity of masseter muscle contractions and/or sleep quality for patients experiencing sleep bruxism (SB). MATERIALS AND METHODS: Twenty patients with SB participated in this clinical study. They were randomly divided into two treatment groups: stabilization splint group (n = 10) and gabapentin group (n = 10). The first polysomnographic examination was performed before the beginning of the experiment for all the participants. At the end of a 2-month period of stabilization splint therapy or gabapentin usage, a second polysomnographic recording was made. RESULTS: Statistically significant reductions in the number of SB episodes per hour and per night, bruxism time index, total duration of SB episodes per night and number of SB episodes in stages NR I and NR II (p < 0.05) were observed in both groups after treatment. Both treatments significantly reduced the mean intensity of masseter muscle contractions during SB episodes. Moreover, the participants treated with gabapentin showed a significant improvement in total sleep time, slow wave sleep (stage III), and sleep efficiency (p < 0.05). CONCLUSIONS: Gabapentin could be an effective treatment modality in SBs, especially in those with poor sleep quality.