Lifestyle Interventions for Chronic Insomnia

Recruiting at 1 trial location

Overseen By Alexa Kane, PsyD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Untreated sleep disorder, Cardiovascular, Diabetes, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how lifestyle changes can help individuals with chronic insomnia (long-term sleep difficulties). It examines the effects of improved diet and increased physical activity on sleep when combined with Cognitive Behavioral Therapy for Insomnia (CBT-I), a common treatment for sleep issues. Participants will either focus on increasing physical activity or receive nutritional education about the Mediterranean diet. Those with chronic insomnia who are not currently following a vegan or Mediterranean diet may be suitable candidates. As an unphased trial, this study provides a unique opportunity to investigate innovative lifestyle changes that could enhance sleep quality.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these lifestyle interventions are safe for patients with chronic insomnia?

Research shows that both exercise and the Mediterranean diet effectively help people with insomnia sleep better.

Studies indicate that regular activities like walking or jogging can improve sleep and reduce bedtime anxiety. Participants who exercised for 30 minutes three times a week reported better sleep. Other activities like yoga and Tai Chi also showed positive effects. These exercises are generally safe.

Focusing on the Mediterranean diet has been linked to better sleep quality and longer sleep. This diet includes plenty of fruits, vegetables, whole grains, and healthy fats like olive oil. Research suggests that people who follow this diet tend to sleep better and experience fewer insomnia symptoms. No major safety issues have been found with this diet.

Both exercise and the Mediterranean diet are safe and generally well-tolerated by most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for chronic insomnia because they incorporate lifestyle changes that could offer long-lasting benefits beyond medication. Unlike traditional options like sleeping pills or standard cognitive behavioral therapy (CBT-I) alone, these treatments introduce two new components: physical activity and nutritional education. The Physical Activity Education approach encourages patients to gradually increase their weekly exercise, potentially boosting sleep quality through natural, holistic means. Meanwhile, the Nutritional Education component focuses on the Mediterranean Diet, providing patients with guidance on healthier eating habits that might improve sleep by enhancing overall health. These strategies aim to empower patients with sustainable habits that address insomnia at its root.

What evidence suggests that this trial's treatments could be effective for chronic insomnia?

Research has shown that regular physical activity, which participants in this trial may receive as part of the Physical Activity Education arm, can help people with insomnia sleep better. For example, exercising three times a week for eight weeks improved sleep. Activities like yoga, Tai Chi, and walking are particularly helpful. Meanwhile, the Nutritional Education arm of this trial will explore the effects of following a Mediterranean diet, which studies suggest can improve sleep quality. People who eat this way often sleep longer and experience fewer insomnia symptoms. Together, these lifestyle changes hold promise for improving sleep in those with chronic insomnia. ^{2 3 6 7 8}

Who Is on the Research Team?

Alexa Kane

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults aged 18-70 with chronic insomnia, but not for those with untreated sleep disorders, cardiovascular issues limiting exercise, diabetes, pregnancy/lactation, current vegan/Mediterranean diet users, BMI ≤22, high depression scores (PHQ-8 >15), shift workers or those with circadian rhythm disorders.

Inclusion Criteria

I have been diagnosed with chronic insomnia.

Exclusion Criteria

I have diabetes.

Pregnancy or lactation

Current use of a vegan diet or Mediterranean diet

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Cognitive Behavioral Therapy for Insomnia (CBT-I) with additional lifestyle interventions including physical activity and nutritional education

12 weeks

Weekly sessions

Follow-up

Participants are monitored for changes in sleep quality and insomnia severity after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Nutritional Education
• Physical Activity

Trial Overview

The study evaluates the effects of a lifestyle intervention on sleep quality in chronic insomnia patients. This includes physical activity and nutritional education alongside traditional Cognitive Behavioral Therapy for Insomnia (CBT-I).

How Is the Trial Designed?

Group I: Physical Activity Education Experimental Treatment 1 Intervention

In addition to the traditional course of CBT-I, the PI will recommend patient to increase physical activity minutes per week. The increase in physical activity will be based on patient's current level of physical activity.

Group II: Nutritional Education Experimental Treatment 1 Intervention

In addition to the traditional course of CBT-I, the PI will provide education and materials regarding the Mediterranean Diet. Patient will be provided with the Mayo Clinic booklet on Mediterranean Diet and asked to increase their daily intake in two categories assessed by the Mini-EAT.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

The pilot study involving 37 inactive adults with insomnia showed that zero-time exercise (ZTEx) significantly reduced insomnia severity compared to sleep hygiene education, with a large effect size observed at weeks two, four, and six.

Although the initial benefits of ZTEx diminished by week eight, the training was well-received, with high adherence rates, indicating its potential as a feasible intervention for improving insomnia in inactive adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Zero-time Exercise on inactive adults with insomnia disorder: a pilot randomized controlled trial. Yeung, WF., Lai, AY., Ho, FY., et al.[2019]

Brief exercise training (ET) counseling is shown to be an efficient and cost-effective method to increase physical activity (PA) among patients, leading to significant health benefits across various disease groups.

To fully integrate exercise as a vital part of healthcare, a fundamental shift is needed in how healthcare systems view and implement ET counseling, treating it with the same importance as pharmaceuticals and other medical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity promotion in the health care system. Vuori, IM., Lavie, CJ., Blair, SN.[2022]

In a study of 71 outpatients with chronic insomnia, combining physical activity counseling with sleep restriction therapy (PASR) significantly increased physical activity levels and daily steps compared to sleep restriction alone.

Patients in the PASR group also experienced better improvements in sleep quality, as measured by the Epworth Sleepiness Scale and Fatigue Scale-14, indicating that this combined approach is effective for enhancing both physical activity and sleep quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of physical activity counseling plus sleep restriction therapy on the patients with chronic insomnia. Wang, J., Yin, G., Li, G., et al.[2020]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10913350/

Mediterranean diet adherence and sleep pattern

Summarizing previous findings, we found that adherence to MD might help sleeping better. Sleep disturbance can be linked to poor health outcomes ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1087079225000243

Sleep and the Mediterranean diet: A systematic review ...

We found that sufficient sleep duration or good-quality sleep was significantly associated with higher MedDiet scores. Moreover, individuals with earlier ...

3.

nutritionj.biomedcentral.com

nutritionj.biomedcentral.com/articles/10.1186/s12937-025-01095-8

The effect of mediterranean diet and chrononutrition on sleep ...

Mediterranean diet demonstrates a more consistent and positive influence on sleep quality compared to chrononutrition.

4.

nature.com

nature.com/articles/s41598-023-40625-4

Association between Mediterranean dietary pattern with ...

We observed that individuals with higher adherence to MD might have better sleep duration and quality. Therefore, clinicians could recommend ...

5.

academic.oup.com

academic.oup.com/sleep/article/41/11/zsy158/5077799

Mediterranean diet pattern and sleep duration and insomnia ...

These results suggest that a Mediterranean-style diet is associated with adequate sleep duration, less insomnia symptoms, and less likely to have insomnia ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9318336/

Mediterranean Diet on Sleep: A Health Alliance - PMC

The available studies indicate that greater adherence to the Mediterranean diet is associated with adequate sleep duration and with several indicators of ...

7.

mdpi.com

mdpi.com/2072-6643/16/2/282

Mediterranean Diet and Sleep Features: A Systematic ...

The systematic review comprised 23 reports describing the relation between adherence to the Mediterranean diet and different sleep features, including sleep ...

8.

journals.lww.com

journals.lww.com/cmj/fulltext/2024/08200/association_of_insomnia_with_diet_quality_and.20.aspx

Association of insomnia with diet quality and eating behavior

In this large-scale cross-sectional study, we observed that individuals with insomnia had lower diet quality and poorer eating behaviors. The unhealthy eating ...