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Lifestyle Interventions for Chronic Insomnia

N/A

Waitlist Available

Led By Alexa Kane

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

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

Must have

Diagnosis of Chronic Insomnia

Age between 18 and 70 years

Must not have

Known untreated sleep disorder

Cardiovascular diagnosis that would not allow safe increase of physical activity

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 14 days, 28 days, 42 days, 56 days, 70 days, 84 days

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to evaluate how well patients with chronic insomnia sleep, eat, and exercise before and after a short lifestyle intervention while receiving Cognitive Behavioral Therapy for Insomnia.

Who is the study for?

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.

What is being tested?

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).

What are the potential side effects?

Since the interventions involve lifestyle changes like increased physical activity and dietary adjustments rather than medication, side effects may include muscle soreness from new exercises or digestive changes due to diet alterations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with chronic insomnia.

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I am between 18 and 70 years old.

Exclusion Criteria

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

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I have a sleep disorder that hasn't been treated.

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

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I have a severe neurological or sensory condition that affects my daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 14 days, 28 days, 42 days, 56 days, 70 days, 84 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 14 days, 28 days, 42 days, 56 days, 70 days, 84 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 14 days, 28 days, 42 days, 56 days, 70 days, 84 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

Change in sleep quality measured by the Pittsburgh Sleep Quality Index

Secondary study objectives

Change in insomnia measured by the Insomnia Severity Index

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Physical Activity EducationExperimental Treatment1 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 EducationExperimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nutritional Education

2017

N/A

~170

Physical Activity

2019

Completed Phase 3

~4760