Sleep Bootcamp: A Pilot Tele-Sleep Program for Former National Football League (NFL) Players

NCT04159233 | Completed

• 1 other identifier: 2019P002027
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study is focused on estimating the impact of a tele-sleep intervention on patient-centered outcomes relevant to former football players, including a) sleep duration, quality, and daytime impairment; b) pain, pain catastrophizing, physical and emotional functioning; c) mood; d) quality of life, with the longer-term goal to evaluate the impact on cardiovascular health risk. The evidence-based 'Brief Behavioral Therapy for Insomnia' (BBTI) will be utilized and tailored it to meet the needs of former football players. This pilot work will serve as the foundation for a larger, future clinical trial that utilizes a durable approach for improving sleep health with potential influence pain and quality of life as well as future studies to evaluate the implementation and scalability of BBTI in novel populations.

Conditions

Sleep; Insomnia; Pain; Quality of Life

Keywords

sleep; pain; professional athlete; National Football League; Behavioral intervention

Outcome Measures

Primary Outcomes (1)

• Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance, 8b Endpoint

  PROMIS Sleep Disturbance measures self-reported sleep quality and associated daytime functioning during the past seven days. The measure includes 8-items with higher scores indicating greater sleep disturbance. The minimum score is 8 and the maximum score is 40. Item responses are combined to yield a T-score with a population mean of 50 and standard deviation of 10.

  Week 4

Secondary Outcomes (13)

• PROMIS Sleep Disturbance, 8b Follow-up

  Week 12

• PROMIS Sleep Impairment, 8a Endpoint

  Week 4

• PROMIS Sleep Impairment, 8a Follow-up

  Week 12

• Response to treatment (baseline to endpoint)

  Week 0 vs. Week 4

• Response to treatment (baseline to follow-up)

  Week 0 vs. Week 12

Study Arms (1)

Adapted 'Brief Behavioral Therapy for Insomnia' (BBTI)

OTHER

All participants will receive the same intervention in this pilot study.

Behavioral: Brief Behavioral Therapy for Insomnia (BBTI)

Interventions

Brief Behavioral Therapy for Insomnia (BBTI) BEHAVIORAL

Participants will receive evidence-based 'Brief Behavioral Therapy for Insomnia' (BBTI), tailored to meet the needs of former football players. BBTi is a brief, efficacious treatment that focuses on modifying behaviors, rather than cognitive domains. The treatment emphasizes education, motivational tools, and specific behavioral recommendations (e.g., restricting time in bed) and will be administered through weekly phone calls with a trained sleep interventionist over 4-weeks.

Adapted 'Brief Behavioral Therapy for Insomnia' (BBTI)

Eligibility Criteria

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

You may qualify if:

• Able to communicate clearly in English
• Have a digital device with reliable internet access
• Sub-clinical insomnia (Insomnia Severity Index, score \>7, sub-clinical threshold insomnia)
• Able to give informed consent

You may not qualify if:

• Prior participation in behavioral therapy for insomnia
• Self-reported circadian phase irregularity/delay, including regular shift work
• Previously diagnosed Narcolepsy, bipolar disorder or other major psychiatric disorders
• Active alcohol abuse (Alcohol Use Disorders Identification Test, AUDIT-C ≥4) or drug abuse (Drug Abuse Screening Test, DAST-2 ≥1)
• Current severe major depressive disorder (Patient Health Questionnaire-8, PHQ-8, score ≥20)
• Use of seizure medication or seizure within the past 10 years
• Untreated, previously diagnosed moderate to severe sleep apnea or excessive daytime sleepiness (defined by Epworth sleepiness scale score ≥16) with a self-reported sleep duration (\>6 hours)

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Harvard Medical School (HMS and HSDM): collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Pain

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Suzanne Bertisch, MD, MPH

  Assistant Professor in Medicine, Physician/Clinical Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: November 12, 2019
• Study Start: January 14, 2020
• Primary Completion: June 30, 2020
• Study Completion: September 7, 2020
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)