Effect of therapeutic touch on daytime sleepiness, stress and fatigue among students of nursing and midwifery: A randomized sham-controlled trial

Abstract Introduction Solriamfetol is a dopamine and norepinephrine reuptake inhibitor indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy (75-150 mg/d) or obstructive sleep apnea (37.5-150 mg/d). Previous studies reported small mean increases in blood pressure (BP); however, the time course of these effects has not been evaluated. In addition, effects on BP dipping, which has been shown to be a risk factor for adverse cardiovascular outcomes, have not been evaluated. These analyses evaluated the effects of solriamfetol treatment on BP using 24-hour ambulatory blood pressure monitoring (ABPM) and on the percentage of narcolepsy patients with a non-dipping BP profile. Methods Twenty-four-hour ABPM was conducted at baseline and week 8 in a 12-week randomized controlled trial in participants with narcolepsy (n=236). Results At week 8, increases in BP were apparent in the 150 and 300 mg dose groups from 8 AM until 4 PM and 6 PM, respectively. At baseline, 52% (placebo) and 48% (combined solriamfetol) of participants were non-dippers (defined as <10% decrease in mean arterial pressure [MAP] during sleep). There was no increase in the percentage of non-dippers at week 8 relative to baseline (placebo, 44%; combined solriamfetol, 39%). Results were similar when dipping was defined by changes in systolic BP and diastolic BP. Conclusion The effects of solriamfetol on BP at the highest approved dose of 150 mg/d are transient across the day. Solriamfetol was not observed to have an increase in non-dipping classification in participants with narcolepsy at any dose studied. Support Jazz Pharmaceuticals

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Tai Chi and Self-Rated Quality of Sleep and Daytime Sleepiness in Older Adults: A Randomized Controlled Trial

Journal of the American Geriatrics Society ◽

10.1111/j.1532-5415.2004.52255.x ◽

2004 ◽

Vol 52 (6) ◽

pp. 892-900 ◽

Cited By ~ 178

Author(s):

Fuzhong Li ◽

K. John Fisher ◽

Peter Harmer ◽

Dainis Irbe ◽

Robert G. Tearse ◽

...

Keyword(s):

Older Adults ◽

Randomized Controlled Trial ◽

Daytime Sleepiness ◽

Tai Chi ◽

Controlled Trial ◽

Quality Of Sleep ◽

Randomized Controlled

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Testing a mindfulness meditation mobile app for the treatment of sleep-related symptoms in adults with sleep disturbance: A randomized controlled trial

PLoS ONE ◽

10.1371/journal.pone.0244717 ◽

2021 ◽

Vol 16 (1) ◽

pp. e0244717

Author(s):

Jennifer L. Huberty ◽

Jeni Green ◽

Megan E. Puzia ◽

Linda Larkey ◽

Breanne Laird ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Sleep Disturbance ◽

Daytime Sleepiness ◽

Controlled Trial ◽

Intervention Group ◽

Mobile App ◽

Wait List ◽

Wait List Control ◽

Randomized Controlled ◽

Sleep Arousal

The objective of this randomized controlled trial was to test whether a commercially available, mindfulness meditation mobile app, (i.e., Calm app), was effective in reducing fatigue (primary outcome), pre-sleep arousal, and daytime sleepiness (secondary outcomes) in adults with sleep disturbance (Insomnia Severity Index Score >10) as compared to a wait-list control group. Associations between the use of the Calm app (i.e., adherence to the intervention) and changes in sleep quality was also explored in the intervention group only. Adults with sleep disturbance were recruited (N = 640). Eligible and consenting participants (N = 263) were randomly assigned to the intervention (n = 124) or a wait-list control (n = 139) group. Intervention participants were asked to meditate using the Calm app ≥10 minutes/day for eight weeks. Fatigue, daytime sleepiness, and pre-sleep arousal were assessed at baseline, mid- (4-weeks) and post-intervention (8-weeks) in both groups, whereas sleep quality was evaluated only in the intervention group. Findings from intent-to-treat analyses suggest the use of the Calm app for eight weeks significantly decreased daytime fatigue (p = .018) as well as daytime sleepiness (p = .003) and cognitive (p = .005) and somatic (p < .001) pre-sleep arousal as compared to the wait-list control group. Within the intervention group, use of the Calm app was associated with improvements in sleep quality (p < .001). This randomized controlled trial demonstrates that the Calm app can be used to treat fatigue, daytime sleepiness, and pre-sleep arousal in adults with sleep disturbance. Given that the Calm app is affordable and widely accessible, these data have implications for community level dissemination of a mobile app to improve sleep-related symptoms associated with sleep disturbance. Trial registration: ClinicalTrials.gov NCT04045275.

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The effect of cognitive and behavioral therapy for insomnia on week-to-week changes in sleepiness and sleep parameters in patients with comorbid insomnia and sleep apnea: a randomized controlled trial

SLEEP ◽

10.1093/sleep/zsaa002 ◽

2020 ◽

Vol 43 (7) ◽

Cited By ~ 4

Author(s):

Alexander Sweetman ◽

R Doug McEvoy ◽

Simon Smith ◽

Peter G Catcheside ◽

Nick A Antic ◽

...

Keyword(s):

Sleep Apnea ◽

Daytime Sleepiness ◽

Behavioral Therapy ◽

Controlled Trial ◽

Sleep Apnoea ◽

Comorbid Insomnia ◽

Randomized Controlled ◽

Obstructive Sleep ◽

Sleep Parameters ◽

Cognitive And Behavioral Therapy

Abstract Study Objectives While cognitive and behavioral therapy for insomnia (CBTi) is an effective treatment in patients with comorbid moderate and severe obstructive sleep apnea (OSA), there is concern that the bedtime restriction component of CBTi might dangerously exacerbate daytime sleepiness in such patients. We examined randomized controlled trial data to investigate the effect of OSA severity, and pretreatment daytime sleepiness on week-to-week changes in daytime sleepiness and sleep parameters during CBTi and no-treatment control. Methods One hundred and forty-five patients with untreated physician-diagnosed OSA (apnea–hypopnea index ≥15) and psychologist-diagnosed insomnia (ICSD-3) were randomized to a 4-week CBTi program (n = 72) or no-treatment control (n = 73). The Epworth sleepiness scale (ESS) and sleep diaries were completed during pretreatment, weekly CBTi sessions, and posttreatment. Effects of OSA severity, pretreatment daytime sleepiness, and intervention group on weekly changes in daytime sleepiness and sleep parameters were investigated. Results The CBTi group reported a 15% increase in ESS scores following the first week of bedtime restriction (M change = 1.3 points, 95% CI = 0.1–2.5, p = 0.031, Cohen’s d = 0.27) which immediately returned to pretreatment levels for all subsequent weeks, while sleep parameters gradually improved throughout CBTi. There were no differences in changes in daytime sleepiness during treatment between CBTi and control groups or OSA-severity groups. Higher pretreatment ESS scores were associated with a greater ESS reduction during CBTi. Conclusions CBTi appears to be a safe and effective treatment in the presence of comorbid moderate and severe OSA. Nevertheless, patients living with comorbid insomnia and sleep apnea and treated with CBTi should be monitored closely for increased daytime sleepiness during the initial weeks of bedtime restriction therapy. Clinical Trial Registration Treating comorbid insomnia with obstructive sleep apnoea (COMISA) study: A new treatment strategy for patients with combined insomnia and sleep apnoea, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id = 365184 Australian New Zealand Clinical Trials Registry: ACTRN12613001178730. Universal Trial Number: U1111-1149-4230.

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The effect of therapeutic touch on labour pain, anxiety and childbirth attitude: A randomized controlled trial

European Journal of Integrative Medicine ◽

10.1016/j.eujim.2020.101255 ◽

2021 ◽

Vol 41 ◽

pp. 101255

Author(s):

Sukran Ertekin Pinar ◽

Gulbahtiyar Demirel

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Labour Pain ◽

Therapeutic Touch ◽

Pain Anxiety ◽

Randomized Controlled

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Daytime sleepiness associated with lurasidone and quetiapine XR: results from a randomized double-blind, placebo-controlled trial in patients with schizophrenia

CNS Spectrums ◽

10.1017/s1092852913000904 ◽

2013 ◽

Vol 19 (2) ◽

pp. 197-205 ◽

Cited By ~ 20

Author(s):

Antony D. Loebel ◽

Cynthia O. Siu ◽

Josephine B. Cucchiaro ◽

Andrei A. Pikalov ◽

Philip D. Harvey

Keyword(s):

Functional Capacity ◽

Daytime Sleepiness ◽

Controlled Trial ◽

Antipsychotic Agents ◽

Placebo Treatment ◽

Double Blind Study ◽

Double Blind ◽

Once Daily ◽

Quetiapine Xr ◽

Atypical Antipsychotic Agents

ObjectiveThe aim of this analysis was to compare the effects of 2 atypical antipsychotic agents, lurasidone (80 mg/d or 160 mg/d) and quetiapine XR (600 mg/d), on daytime alertness, and to evaluate the effects of daytime sleepiness on treatment outcomes in patients with an acute exacerbation of schizophrenia.MethodsPatients who met Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision (DSM-IV-TR) criteria for schizophrenia were randomized to 6 weeks of double-blind treatment with fixed doses of lurasidone 80 mg/d (n = 125), lurasidone 160 mg/d (n = 121), quetiapine XR 600 mg/d (n = 119), or placebo (n = 121), all dosed once daily in the evening, with food. Daytime sleepiness was assessed using the Epworth Sleepiness Scale (ESS).ResultsDaytime sleepiness improved in the lurasidone and placebo-treated groups but worsened in the quetiapine XR treatment group when compared to placebo (p = 0.001) and to either dose of lurasidone (both p < 0.01). Sedation associated with quetiapine XR treatment mediated an improvement in agitation [assessed by the Positive and Negative Syndrome Scale—Excitement (PANSS-EC) subscale] and a worsening in functional capacity [assessed by the University of California–San Diego (UCSD) Performance-Based Skills Assessment—Brief Version (UPSA-B) total score]; these mediating relationships were not observed for the lurasidone or placebo treatment groups.ConclusionIn this 6-week double-blind study, treatment with lurasidone 80 mg or 160 mg, administered once daily in the evening, was associated with a reduction in daytime sleepiness similar in magnitude to placebo, while quetiapine XR 600 mg/d was associated with a significant increase in daytime sleepiness, compared to both lurasidone dose groups and placebo. Daytime sleepiness was associated with improvement in agitation and worsening in functional capacity for quetiapine XR, but not lurasidone or placebo-treated patients.

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Randomized controlled trial of exercise interventions to improve sleep quality and daytime sleepiness in individuals with multiple sclerosis: A pilot study

Multiple Sclerosis Journal - Experimental Translational and Clinical ◽

10.1177/2055217316680639 ◽

2016 ◽

Vol 2 ◽

pp. 205521731668063 ◽

Cited By ~ 4

Author(s):

Catherine F Siengsukon ◽

Mayis Aldughmi ◽

Melike Kahya ◽

Jared Bruce ◽

Sharon Lynch ◽

...

Keyword(s):

Multiple Sclerosis ◽

Randomized Controlled Trial ◽

Sleep Quality ◽

Daytime Sleepiness ◽

Controlled Trial ◽

Moderate Intensity ◽

Exercise Interventions ◽

Moderate Improvement ◽

Randomized Controlled ◽

Improve Sleep Quality

Background Nearly 70% of individuals with multiple sclerosis (MS) experience sleep disturbances. Increasing physical activity in people with MS has been shown to produce a moderate improvement in sleep quality, and exercise has been shown to improve sleep quality in non-neurologically impaired adults. Objective The purpose of this pilot randomized controlled trial study was to examine the effect of two exercise interventions on sleep quality and daytime sleepiness in individuals with MS. Methods Twenty-eight individuals with relapsing–remitting or secondary progressive MS were randomized into one of two 12-week exercise interventions: a supervised, moderate-intensity aerobic exercise (AE) program or an unsupervised, low-intensity walking and stretching (WS) program. Only individuals who were ≥ 70% compliant with the programs were included in analysis ( n = 12 AE; n = 10 WS). Results Both groups demonstrated a moderate improvement in sleep quality, although only the improvement by the WS group was statistically significant. Only the AE group demonstrated a significant improvement in daytime sleepiness. Change in sleep quality and daytime sleepiness was not correlated with disease severity or with change in cardiovascular fitness, depression, or fatigue. Conclusion The mechanisms for improvement in sleep quality and daytime sleepiness need further investigation, but may be due to introduction of zeitgebers to improve circadian rhythm.

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