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Insomnia ChronicNCT06550388

Subjective Sleep Quality of Patients With Chronic Insomnia

A study testing Nutritional Education and Physical Activity in people with Insomnia Chronic, run by Mayo Clinic at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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) Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Insomnia Chronic
What is being tested?
Nutritional Education and Physical Activity
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
2 sitesUnited States
Study dates
10 Sep 2024to 31 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of Chronic Insomnia
  • 18-70 years of age

Who cannot join

  • Known untreated sleep disorder
  • Cardiovascular diagnosis that would not allow safe increase of physical activity
  • Diabetes
  • Pregnancy or lactation
  • Current use of a vegan diet or Mediterranean diet
  • BMI ≤ 22
Show all 9Show fewer
  • Score higher than 15 on PHQ-8
  • Diagnosed with a severe neurological or sensory impairment that would significant impact participation
  • Currently performing shift work/diagnosis of a circadian rhythm disorder

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224

  • Mayo Clinic

    Jacksonville, Florida, 32224

Other trials in United States

About this study

Official title: Effect of Brief Lifestyle Interventions on the Subjective Sleep Quality of Patients With Chronic Insomnia

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)

Read the detailed description

Chronic insomnia disorder is highly prevalent, occurring in 4% to 22% of the population in the U.S. The consequences of chronic insomnia are significant including mood disorders, work-related and motor vehicle accidents, and overall poor quality of life. Lack of sleep satisfaction, a hallmark of chronic insomnia, is associated with metabolic syndrome, diabetes, hypertension, coronary heart disease and depression1.

Chronic insomnia is predominantly managed with hypnotics and other medications despite the effectiveness of and patient preference for CBT-I. The American College of Physicians (ACP) and the American Academy of Sleep Medicine (AASM) guidelines for management of chronic insomnia recommend all patients receive Cognitive Behavioral Therapy for Insomnia (CBT-I) as first line treatment for chronic insomnia2,3. CBT-I is a structured, nonpharmacological treatment that uses educational, cognitive, and behavioral strategies. Meta-analyses have shown CBT-I is consistently associated with improved sleep quality in chronic insomnia with or without comorbidities4,5. While the strategies associated with CBT-I have been found to be effective for the management of chronic insomnia, lifestyle intervention to improve patients' diet and physical activity is not part of traditional CBT-I. The field of behavioral sleep medicine can expand interventional strategies to promote health and well-being while also optimizing sleep health.

A pathway to improve sleep health is a shift from a typical medicine perspective which emphasizes identification and treatment of symptoms, to a health promotion perspective, which emphasizes the promotion of overall well-being. Incorporating principles from lifestyle medicine and behavioral sleep medicine can both identify and treat sleep disorders plus promote overall health including education regarding diet quality and exercise. Targeting diet quality and physical activity education within the context of CBT-I will underscore the importance of nonpharmacological treatment and the promotion of health and well-being which is central to behavioral sleep and lifestyle medicine.

The etiology of chronic insomnia disorder is multifactorial with research supporting poor diet and lack of physical activity as contributing factors to poor sleep. Previous studies have reported higher diet quality promotes better sleep quality and mental health. Sleep deprivation and sleep disturbances have been linked to poor diet quality. Eating too quickly or skipping meals, overabundant meals, irregular mealtimes, and poor food quality, all are dietary causes of sleep disorders. Additionally, the timing of meals, including frequency and regularity of snacks, may desynchronize circadian rhythm, affect metabolism, and favor obesity6. There is mounting evidence suggesting sleep influences dietary choices as well. Individuals who sleep less are more likely to prefer energy-rich foods (e.g., fats and refined carbohydrates), eat fewer vegetables, and choose irregular eating patterns7.

Additionally, several pathways have been proposed regarding benefits of the Mediterranean diet and healthy dietary patterns on sleep, including the role of the gut microbiome8, inflammation and the consumption of dietary tryptophan and melatonin9. Some observational studies have shown a high intake of fruit and vegetables is associated with better sleep quality and lower risk of insomnia while a cohort study of older adults in Spain showed that higher consumption of red meat was associated with poor sleep quality and snoring10,11.

Recent studies have also highlighted the importance of physical activity and the impact on sleep quality. Low levels of physical activity have been reported as significant risk factors for both prevalent and incident insomnia12. One study documented improvements in sleep after days with more acute moderate-intensity activity in patients diagnosed with chronic insomnia13. Physical activity and sleep likely influence each other in both physiological and psychological pathways. For example, in older adults, increasing physical activity has been shown to improve excessive daytime sleepiness and reduce prevalence of insomnia symptoms14. Although there have been studies assessing the association between sleep quality and physical activity, very little has looked at patients diagnosed with chronic insomnia and we believe this is the first study to add a brief lifestyle intervention to traditional CBT-I.

There is support for the inclusion of healthy diet education and increased physical activity in interventions programs, such as CBT-I, to improve sleep quality among individuals diagnosed with chronic insomnia. Combining health promoting behaviors in conjunction with CBT-I is likely to be of great importance in preventing a large set of chronic non-communicable disease. At the very least, the combination of traditional CBT-I with healthy diet education and physical education may increase sleep quality, diet quality and physical activity for patients diagnosed with chronic insomnia.

Being tested
Nutritional Education, Physical Activity
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nutritional EducationBehavioural

    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.

  • Physical ActivityBehavioural

    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.

Study groups in NCT06550388
Study groupRoleWhat they receive
Physical Activity EducationOtherIn 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.
Receives: Behavioral: Physical Activity
Nutritional EducationOtherIn 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.
Receives: Behavioral: Nutritional Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in sleep quality measured by the Pittsburgh Sleep Quality Index

    Measures the severity of sleep disturbances. Possible scores range from 0 to 21 with higher scores indicating a worse outcome/more severe symptoms of sleep disturbance.

    Measured: Baseline, 84 days

Secondary outcomes (1)
  1. Change in insomnia measured by the Insomnia Severity Index

    Self-reported insomnia severity index questionnaire score, using a total score, scale of 0-7 is no clinically significant insomnia, 8-14 is subthreshold insomnia, 15-21 is clinical insomnia (moderate severity), 22-28 is Clinical insomnia (severe)

    Measured: Baseline, 14 days, 28 days, 42 days, 56 days, 70 days, 84 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2024
  2. Study start10 Sep 2024
  3. Primary completion31 Dec 2025
  4. Study completion31 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06550388
Sponsor's protocol ID
24-004753
Status last verified
Feb 2026
First submitted
22 Jul 2024
Last updated
13 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Nutritional Education and Physical Activity in people with Insomnia Chronic, run by Mayo Clinic at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in sleep quality measured by the Pittsburgh Sleep Quality Index (time frame: Baseline, 84 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.

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