Subjective Sleep Quality of Patients With Chronic Insomnia

NCT06550388 | Completed

• 1 other identifier: 24-004753
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

Brief 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)

Conditions

Insomnia Chronic

Outcome Measures

Primary Outcomes (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.

  Baseline, 84 days

Secondary Outcomes (1)

• Change in insomnia measured by the Insomnia Severity Index

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

Study Arms (2)

Physical Activity Education

OTHER

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.

Behavioral: Physical Activity

Nutritional Education

OTHER

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.

Behavioral: Nutritional Education

Interventions

Physical Activity BEHAVIORAL

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.

Physical Activity Education

Nutritional Education BEHAVIORAL

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.

Nutritional Education

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Chronic Insomnia
• years of age

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Exercise

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Alexa Kane

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: August 13, 2024
• Study Start: September 10, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)