8-h Afternoon-Evening Sleep for Parasomnias

Phase-Based Estimates
1
Effectiveness
1
Safety
Brigham and Women's Hospital, Boston, MA
Parasomnias+5 More
8-h Afternoon-Evening Sleep - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Parasomnias

Study Summary

This study is evaluating whether an 8-hour sleep intervention may help improve sleep for older night workers.

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Eligible Conditions

  • Parasomnias
  • Sleep Disorders
  • Shift-Work Sleep Disorder
  • Dyssomnias
  • Sleep Wake Disorders
  • Shift-Work Related Sleep Disturbance
  • Sleep Disorders, Circadian Rhythm
  • Shift-work related sleep disturbance

Treatment Effectiveness

Study Objectives

This trial is evaluating whether 8-h Afternoon-Evening Sleep will improve 11 primary outcomes and 4 secondary outcomes in patients with Parasomnias. Measurement will happen over the course of Subjective Alertness via VAS measurements taken at the end of the final night shift (night shift 3) in the intervention block will be compared between groups..

OFER15 scores from the end of the third night shift in the Intervention block will be compared between groups.
Fatigue and Inter-Shift Recovery
PVT mean lapses of attention measured at the end of the final night shift (night shift 3) during the intervention block will be compared between groups.
Sustained Attention
Salivary Cortisol will be assessed immediately after the third night shift in the Intervention block and levels will be compared between groups.
Salivary Cortisol Level
Subjective Alertness via VAS measurements taken at the end of the final night shift (night shift 3) in the intervention block will be compared between groups.
Subjective Alertness via Visual Analog Scale (VAS)
Subjective Calmness via VAS measurements taken at the end of the final night shift (night shift 3) in the intervention block will be compared between groups.
Subjective Calmness via Visual Analog Scale (VAS)
Subjective Energy measurements taken at the end of the final night shift (night shift 3) in the intervention block will be compared between groups.
Subjective Energy
Subjective Health via VAS measurements taken at the end of the final night shift (night shift 3) in the intervention block will be compared between groups.
Subjective Health via Visual Analog Scale (VAS)
Subjective Sleep quality (refreshment) averaged for intervention nights 2 and 3 will be compared between groups.(
Subjective Sleep Quality
Subjective Stress via VAS measurements taken at the end of the final night shift (night shift 3) in the intervention block will be compared between groups.
Subjective Stress via Visual Analog Scale (VAS)
Subjective stress will be assessed immediately after the third night shift in the Intervention block and will be compared between groups.
Subjective Stress
The FI averaged for intervention nights 2 and 3 will be compared between groups.
Sleep Fragmentation Index (FI)
The KSS score taken at the end of the final night shift (night shift 3) during the intervention block will be compared between groups.
Subjective Alertness via Karolinska Sleepiness Scale (KSS)
The TST averaged for intervention nights 2 and 3 (in minutes) will be compared between groups.
Total Sleep Time (TST)
The WASO averaged for intervention nights 2 and 3 will be compared between groups.
Wake After Sleep Onset (WASO)
WHOQOL-Bref will be taken immediately after the third night shift in the Intervention block and will be compared between groups.
Subjective Quality of Life: WHOQOLBref

Trial Safety

Trial Design

2 Treatment Groups

No Control Group
8-h Afternoon-Evening Sleep (Group B)

This trial requires 75 total participants across 2 different treatment groups

This trial involves 2 different treatments. 8-h Afternoon-Evening Sleep is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

8-h Afternoon-Evening Sleep (Group B)
Behavioral
In the 8-h afternoon-evening sleep intervention group (Group B), participants will be instructed to go to bed between 13:00 and 14:00 (depending on their individual commute time) and to remain in bed attempting to sleep for 8 hours (until 21:00-22:00) before the next two night shifts.
8-h Free Sleep (Group C)
Behavioral
In the 8-h free sleep group (Group C), participants will be instructed to remain in bed for 8 continuous hours before the next two night shifts, but will not be given any instruction regarding which 8 hours they should sleep.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: salivary cortisol will be assessed immediately after the third night shift in the intervention block and levels will be compared between groups.
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly salivary cortisol will be assessed immediately after the third night shift in the intervention block and levels will be compared between groups. for reporting.

Who is running the study

Principal Investigator
J. D.
Jeanne Duffy, Principal Investigator
Brigham and Women's Hospital

Closest Location

Brigham and Women's Hospital - Boston, MA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
I must be able to work eight consecutive eight-hour night shifts over the course of two weeks. show original
Must report an ability to spend 8 consecutive hours in bed attempting to sleep. show original
Field Trial -
Age 50-65 years
Health care workers who work a minimum of 4 night shifts (8-4) per month
The person must live in the Boston metropolitan area. show original
Must have a typical commute time between home and place of work of less than one hour

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get parasomnias a year in the United States?

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Hospitalizations for sleep disturbances tripled between the years 1982-1985 and 1992-1995. Most hospitalizations are not due to sleep deprivation. The number of sleep-related readmissions fell from 1992-1995, possibly due to heightened awareness of this problem in the medical community. Patients may be discharged sooner and they are less likely to need hospitalization when they are readmitted. Recent findings may have been affected by the development of the health maintenance organization system. The number of hospitalizations for sleep-related diagnoses (benign and non-benign sleep disorders) is low.

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What is parasomnias?

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It is considered as any sleep-related event such as a parasomnia, hypersomnia or hypnagogia. Parasomnias were also reported by patients after aneurysmal subarachnoid hemorrhage. The sleep can present as hallucinations, illusions, auditory experiences during sleep, or sleep-paroxysmal movements. Parasomnias are related to REM sleep. We have established five types of parasomnias, which are classified as the following:\n1. Pregnancy-related:\n2. Paroxysmal non-rapid eye movement:\n3. Rapid eye movement (REM) sleep paralysis:\n4. Paresis-related:\n5.

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What causes parasomnias?

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There are a variety of possible causes of sleep-related problems, including sleep debt, daytime drowsiness, sleep-related breathing disturbances and low energy levels and there is strong evidence that circadian and sleep problems can interact. These can be primary or secondary. If these problems are related to a particular syndrome, it may be that the sleep disturbance is the primary event and that the other symptoms develop as a result. Parasomnias cannot be classified as a discrete entity because of the variability of such complaints and the difficulty in assessing the extent to which the sleep disturbance is the precipitant of the other symptoms.

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What are the signs of parasomnias?

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Most cases of sleepwalking occur in early childhood; however, one case of parasomnia occurred in a 46-year-old man with a history of nocturnal enuresis and insomnia. In this case, the symptoms may be similar to those seen during daytime sleepwalking and can complicate differential diagnosis. Sleep walking can include sleep talking, and other sleep related non-rapid eye movement behavior.

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What are common treatments for parasomnias?

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Parasomnias tend to be treated by the patient's own doctors using a combination of behavioral therapy and medications. If the patient sees a mental health professional they will usually prescribe a more definitive behavioral intervention, while having a medication as a third-line treatment will be common. As more behavioral treatment options are tried they are either added or removed on a case-by-case basis depending on their benefit to the patient. Finally there is no one-size fit-all treatment to help with the symptoms of a patient with parasomnias. It is not possible to recommend one medication because there is not enough data on which medications are most effective.

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Can parasomnias be cured?

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Although often treated with antipsychotic medication, approximately one third of patients did not respond and had long-term or permanent sequelae due to their sleep disorders.

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Have there been any new discoveries for treating parasomnias?

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While the number of treatments for individual sleep disorders has remained unchanged, some new treatments have been reported for parasomnias, including the use of melatonin (melatonin agonist) for idiopathic hypersomnia, and zonisamide for restless legs syndrome. While there is growing evidence that antidepressants can be used in sleep disorders, a large, well-designed clinical trial is needed to confirm that antidepressants are safe and effective for treating the underlying core problems of idiopathic hypersomnia and restless legs syndrome.

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What is the average age someone gets parasomnias?

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Parasomnias is a very common sleep disorder; however, the average age someone gets them is under 41 years. It is likely that older adults are more likely to have nocturnal enuresis and nighttime pain. Sleep disorder was the most common cause of insomnia. Older adults might have sleep disordered breathing, and younger adults might have sleep paralysis.

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What are the common side effects of 8-h afternoon-evening sleep?

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Results from a recent clinical trial of this study revealed the common side effects of 8-h afternoon-evening sleep in women. Subjects complained of various symptoms of headache, dizziness, irritability, dry mouth, and the like. In spite of insomnia or daytime drowsiness resulting in a fall in cognitive function, these symptoms in most cases did not impact work efficiency or social interactions. However, people experiencing these symptoms should keep in line with the advice they receive from a psychiatrist or medical doctor.

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Does 8-h afternoon-evening sleep improve quality of life for those with parasomnias?

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The poor quality of sleep, daytime sleepiness, and fatigue associated with parasomnias are known to reduce a person's Quality of Life. Recent findings found that the addition of a healthy 8-h period of sleep in the afternoon improves Quality of Life in those with parasomnias.

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Is 8-h afternoon-evening sleep safe for people?

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The current study has found no evidence to support a link between sleep disturbances and sleep-related accidents and injuries. It is possible that sleep-related injuries can occur during daytime, after one has become sleepy, and may, therefore, have different pathophysiologies.

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Is 8-h afternoon-evening sleep typically used in combination with any other treatments?

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Sleep is not typically used in combination with other treatments in patients with somnipathy. However, in the presence of this condition, a daytime nap, which has been used extensively for several years, should not be ignored.

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