Sleep Bootcamp: A Pilot Tele-Sleep Program for Former National Football League (NFL) Players
Completed · Not applicable
Conditions studied: Sleep, Insomnia, Pain, Quality of Life
In brief
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.
Key facts
- Study ID
- NCT04159233
- Run by
- Brigham and Women's Hospital
- People needed
- 42
- Starts
- 2020-01-14
- Expected to finish
- 2020-09-07
- Last updated by the study team
- 2020-09-16
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
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)
Where it is running
- Brigham and Women's Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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