Lifestyle Interventions for Chronic Insomnia

Recruiting at 1 trial location

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

Trial Summary

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 data supports the effectiveness of this treatment for chronic insomnia?

Research shows that increasing physical activity, such as moderate aerobic exercise, can improve sleep quality and reduce insomnia symptoms. Studies also indicate that physical activity combined with sleep education or therapy can enhance sleep and mood in people with chronic insomnia. ^{1 2 3 4 5}

Is lifestyle intervention for chronic insomnia safe for humans?

Lifestyle interventions like physical activity and nutrition education are generally safe for humans. Studies show they can improve health habits and reduce obesity without significant safety concerns. ^{6 7 8 9 10}

How does the lifestyle intervention treatment for chronic insomnia differ from other treatments?

The lifestyle intervention for chronic insomnia is unique because it focuses on increasing physical activity and dietary changes rather than medication. This approach aims to improve sleep quality by incorporating moderate exercise and optimizing nutrient intake, which can enhance mood and reduce insomnia symptoms without the side effects often associated with drugs. ^{1 3 4 5 11}

What is the purpose of this trial?

The purpose of this study is to assess subjective sleep quality, diet quality, physical activity in patients with chronic insomnia before and after a brief lifestyle intervention during a traditional course of Cognitive Behavioral Therapy for Insomnia (CBT-I)

Research Team

Alexa Kane

Principal Investigator

Mayo Clinic

Eligibility Criteria

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 a sleep disorder that hasn't been treated.

My heart condition prevents me from safely increasing my physical activity.

I have diabetes.

Timeline

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

Treatment Details

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).

Participant Groups

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+

Findings from Research

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Aerobic exercise improves self-reported sleep and quality of life in older adults with insomnia. [2022]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Efficacy of physical activity counseling plus sleep restriction therapy on the patients with chronic insomnia. [2020]

3. Netherlands pubmed.ncbi.nlm.nih.gov

High or increasing levels of physical activity protect women from future insomnia. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Increased physical activity improves sleep and mood outcomes in inactive people with insomnia: a randomized controlled trial. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of Zero-time Exercise on inactive adults with insomnia disorder: a pilot randomized controlled trial. [2019]

6. England pubmed.ncbi.nlm.nih.gov

The effect of advice to walk 2000 extra steps daily on food intake. [2007]

7. England pubmed.ncbi.nlm.nih.gov

A systematic review of randomized controlled trials on the effectiveness of computer-tailored physical activity and dietary behavior promotion programs: an update. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Physical activity promotion in the health care system. [2022]

9. Venezuela pubmed.ncbi.nlm.nih.gov

[Evaluation of a nutrition education and physical activity intervention in Chilean low socioeconomic women]. [2016]

10. United States pubmed.ncbi.nlm.nih.gov

Fit & Strong! Plus Trial Outcomes for Obese Older Adults with Osteoarthritis. [2021]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of Six-Month Diet Intervention on Sleep among Overweight and Obese Men with Chronic Insomnia Symptoms: A Randomized Controlled Trial. [2018]