What is the mechanism of action of this treatment?

Common treatments for Shift Work Sleep Disorder (SWSD) include pharmacological options like melatonin and melatonin agonists such as tasimelteon, which help regulate the sleep-wake cycle by mimicking the body's natural sleep hormone. Nonpharmacological interventions include light therapy, which adjusts the circadian rhythm through timed exposure to bright light. Dietary interventions that modulate glycemic control can also play a role by stabilizing blood sugar levels, potentially reducing nighttime awakenings and improving sleep quality. These treatments are essential for SWSD patients as they help align their sleep-wake cycles with their work schedules, enhancing alertness, performance, and overall health.

What side effects are associated with this type of intervention?

Common treatments for Shift Work Sleep Disorder (SWD) include exogenous melatonin, cognitive behavioral therapy for insomnia (CBT-I), and wake-promoting agents such as modafinil or armodafinil. Exogenous melatonin, typically used in doses of 1 to 3 mg, may cause side effects like daytime sleepiness and dizziness. CBT-I, which focuses on sleep scheduling and light exposure, generally has minimal side effects but requires patient adherence and motivation. Wake-promoting agents like modafinil or armodafinil can cause headaches, nausea, nervousness, and potential cardiovascular issues. These treatments aim to realign circadian rhythms and improve alertness, but their side effects must be managed carefully.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Shift Work Sleep Disorder (SWSD), including modafinil (Provigil) and armodafinil (Nuvigil), which are wakefulness-promoting agents. These medications help improve wakefulness in individuals with excessive sleepiness due to SWSD. While the trial on dietary intervention for glycemic control focuses on dietary factors, it does not directly relate to these pharmacologic treatments. However, maintaining glycemic control through diet can be an adjunctive strategy to improve overall health and potentially enhance the effectiveness of pharmacologic treatments for SWSD.

What other types of research exist?

Promising novel alternatives to dietary intervention for glycemic control in Shift Work Sleep Disorder patients include glucagon-like peptide-1 receptor agonists (GLP-1 RAs) such as semaglutide, and alpha-glucosidase inhibitors like acarbose and miglitol. These medications can help manage blood glucose levels effectively.

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Meal Service for Night Shift Workers

N/A

Recruiting

Research Sponsored by State University of New York at Buffalo

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Diagnosis of kidney disease or impairment

Taking medication to lower blood glucose

Timeline

Screening 3 weeks

Treatment Varies

Follow Up two weeks

Awards & highlights

Summary

This trial is testing if changing the amount of protein and carbohydrates in meals can help control blood sugar levels in night shift EMS workers. The study will monitor participants' blood sugar and activity levels while they follow different meal plans. The goal is to find a diet that helps keep their blood sugar stable during night shifts.

Who is the study for?

This trial is for night shift EMS providers who have been working nights for at least a year and whose main job is patient care. It's not open to those with metabolic diseases like diabetes, pregnant women or those planning pregnancy, people with kidney disease, food allergies/intolerances, digestive disorders, or on blood glucose-lowering meds.

What is being tested?

The study tests how meal services can affect blood sugar control in night shift EMS workers. It will also assess if it's practical to implement such a dietary intervention within this workforce.

What are the potential side effects?

Since the intervention involves meal service without medical treatments or drugs, side effects are minimal but may include potential food-related reactions based on individual tolerances.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with kidney disease.

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I am on medication to control my blood sugar.

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I have been diagnosed with a metabolic disease like diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ four days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~four days

This trial's timeline: 3 weeks for screening, Varies for treatment, and four days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Compliance

Glycemic control

Secondary study objectives

Perceived stress

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: High proteinActive Control1 Intervention

Consuming a meal composed of 2:1 grams of protein to carbohydrate during the night shift between 7pm-7am

Group II: Moderate proteinPlacebo Group1 Intervention

Consuming a meal composed of 1:1 grams of protein to carbohydrate during the night shift between 7pm-7am

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Shift Work Sleep Disorder (SWSD) include pharmacological options like melatonin and melatonin agonists such as tasimelteon, which help regulate the sleep-wake cycle by mimicking the body's natural sleep hormone. Nonpharmacological interventions include light therapy, which adjusts the circadian rhythm through timed exposure to bright light. Dietary interventions that modulate glycemic control can also play a role by stabilizing blood sugar levels, potentially reducing nighttime awakenings and improving sleep quality. These treatments are essential for SWSD patients as they help align their sleep-wake cycles with their work schedules, enhancing alertness, performance, and overall health.

SHIFTPLAN: a randomized controlled trial investigating the effects of a multimodal shift-work intervention on drivers' fatigue, sleep, health, and performance parameters.Improving fatigue risk management in healthcare: A scoping review of sleep-related/ fatigue-management interventions for nurses and midwives (reprint).Shift work sleep disorder: burden of illness and approaches to management.