Clinical trial NCT04159233: Sleep Bootcamp: A Pilot Tele-Sleep Program for Former National Football League (NFL) Players
Official title: Pilot Study: Developing A Scalable Sleep Health Intervention to Improve Pain, Quality of Life, and Health in Former NFL Players
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Insomnia
Pain
Quality of Life
Keywords: sleep
pain
professional athlete
National Football League
Behavioral intervention
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Harvard Medical School (HMS and HSDM)
First posted: 2019-11-12
Enrollment: 42
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: The investigators will plan to enroll 40 participants. Players will be recruited from the Harvard Football Players Health Study cohort from across the US via email and telephone invitations. Following screening, if the participant is eligible and interested, they may consent to enroll in the study. 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). BBTI has been previously delivered remotely and this intervention will be delivered by phone by sleep interventionists including trained social workers, psychologists, and nurse practitioners. Participants will complete an intake session with their interventionist followed by a 'treatment session' a week later wherein the interventionist will provide education about sleep regulation and create an individualized schedule of sleep/wake times for the participant. This will be followed by 3 brief weekly check-in calls to review progress, address questions and concerns, and adjust the behavioral treatment plan as the participant progresses. The participant will complete a daily sleep diary throughout the intervention to inform the treatment. Participants will also complete baseline, endpoint and follow-up questionnaires to assess outcomes and intervention acceptability and feasibility. Participants will receive compensation for their participation.

Eligibility criteria: Inclusion criteria

* 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

Exclusion criteria

* 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)

Primary outcomes:
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance, 8b Endpoint
timeFrame: Week 4
Secondary outcomes:
measure: PROMIS Sleep Disturbance, 8b Follow-up
timeFrame: Week 12
measure: PROMIS Sleep Impairment, 8a Endpoint
timeFrame: Week 4
measure: PROMIS Sleep Impairment, 8a Follow-up
timeFrame: Week 12
measure: Response to treatment (baseline to endpoint)
timeFrame: Week 0 vs. Week 4
measure: Response to treatment (baseline to follow-up)
timeFrame: Week 0 vs. Week 12
measure: Remission of poor sleep symptoms (baseline to endpoint)
timeFrame: Week 0 vs. Week 4
measure: Remission of poor sleep symptoms (baseline to follow-up)
timeFrame: Week 0 vs. Week 12
measure: PROMIS Pain intensity, 3a (Endpoint)
timeFrame: Week 4
measure: PROMIS Pain intensity, 3a (Follow-up)
timeFrame: Week 12
measure: PROMIS Pain interference, 8a (Endpoint)
timeFrame: Week 4
measure: PROMIS Pain interference, 8a (Follow-up)
timeFrame: Week 12
measure: Insomnia Severity Index, ISI (Endpoint)
timeFrame: Week 4
measure: Insomnia Severity Index, ISI (Follow-up)
timeFrame: Week 12
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Assistant Professor in Medicine, Physician/Clinical Investigator
name: Suzanne Bertisch, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: