- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04159233
Sleep Bootcamp: A Pilot Tele-Sleep Program for Former National Football League (NFL) Players
Pilot Study: Developing A Scalable Sleep Health Intervention to Improve Pain, Quality of Life, and Health in Former NFL Players
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
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Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Adapted 'Brief Behavioral Therapy for Insomnia' (BBTI)
All participants will receive the same intervention in this pilot 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) and will be administered through weekly phone calls with a trained sleep interventionist over 4-weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance, 8b Endpoint
Time Frame: Week 4
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PROMIS Sleep Disturbance, 8b Follow-up
Time Frame: Week 12
|
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 12
|
PROMIS Sleep Impairment, 8a Endpoint
Time Frame: Week 4
|
PROMIS Sleep Impairment measures self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness during the past seven days.
The measure includes 8-items with higher scores indicating greater sleep impairment.
The minimum score is 8 and the maximum score 40.
Item responses are combined to yield a T-score with a population mean of 50 and standard deviation of 10.
|
Week 4
|
PROMIS Sleep Impairment, 8a Follow-up
Time Frame: Week 12
|
PROMIS Sleep Impairment measures self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness 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 40.
Item responses are combined to yield a T-score with a population mean of 50 and standard deviation of 10.
|
Week 12
|
Response to treatment (baseline to endpoint)
Time Frame: Week 0 vs. Week 4
|
Previous 'Brief Behavioral Treatment for Insomnia' interventions have defined response to treatment as a change in the PSQI score of ≥3 points (Buysse, 2011).
The PSQI, or the Pittsburgh Sleep Quality Index, is a validated instrument which assesses self-reported sleep quality and disturbances over a 1-month interval.
The minimum score is 0 and maximum score is 21.
Higher scores indicate worse sleep quality.
|
Week 0 vs. Week 4
|
Response to treatment (baseline to follow-up)
Time Frame: Week 0 vs. Week 12
|
Previous 'Brief Behavioral Treatment for Insomnia' interventions have defined response to treatment as a change in the PSQI score of ≥3 points (Buysse, 2011).
The PSQI, or the Pittsburgh Sleep Quality Index, is a validated instrument which assesses self-reported sleep quality and disturbances over a 1-month interval.
The minimum score is 0 and maximum score is 21.
Higher scores indicate worse sleep quality.
|
Week 0 vs. Week 12
|
Remission of poor sleep symptoms (baseline to endpoint)
Time Frame: Week 0 vs. Week 4
|
Previous 'Brief Behavioral Treatment for Insomnia' interventions have defined remission as the response criterion (change in the PSQI score of ≥3 points) plus a final PSQI score <5 (Buysse, 2011).
The PSQI, or the Pittsburgh Sleep Quality Index, is a validated instrument which assesses self-reported sleep quality and disturbances over a 1-month interval.
The minimum score is 0 and maximum score is 21.
Higher scores indicate worse sleep quality.
|
Week 0 vs. Week 4
|
Remission of poor sleep symptoms (baseline to follow-up)
Time Frame: Week 0 vs. Week 12
|
Previous 'Brief Behavioral Treatment for Insomnia' interventions have defined remission as the response criterion (change in the PSQI score of ≥3 points) plus a final PSQI score <5 (Buysse, 2011).
The PSQI, or the Pittsburgh Sleep Quality Index, is a validated instrument which assesses self-reported sleep quality and disturbances over a 1-month interval.
The minimum score is 0 and maximum score is 21.
Higher scores indicate worse sleep quality.
|
Week 0 vs. Week 12
|
PROMIS Pain intensity, 3a (Endpoint)
Time Frame: Week 4
|
PROMIS Pain intensity 3a is a self-report measure that assesses how much a person hurts (intensity or severity) in the past 7 days.
The measure includes three items rating pain from "Had no pain" = 1 to "Very severe" = 5, therefore the response range is 3-15 with higher scores indicating greater pain intensity.
Item responses are combined to yield a T-score with population mean of 50 and standard deviation of 10.
|
Week 4
|
PROMIS Pain intensity, 3a (Follow-up)
Time Frame: Week 12
|
PROMIS Pain intensity 3a is a self-report measure that assesses how much a person hurts (intensity or severity) in the past 7 days.
The measure includes three items rating pain from "Had no pain" = 1 to "Very severe" = 5, therefore the response range is 3-15 with higher scores indicating greater pain intensity.
Item responses are combined to yield a T-score with population mean of 50 and standard deviation of 10.
|
Week 12
|
PROMIS Pain interference, 8a (Endpoint)
Time Frame: Week 4
|
PROMIS Pain interference 8a assesses self-reported consequences of pain on relevant aspects of one's life in the past 7 days. The measure includes 8-items rating pain from "Not at all" = 1 to "Very much" = 5, therefore the response range is 8-40 with higher scores indicating greater pain interference. Item responses are combined to yield a standardized T-score with a mean of 50, and a standard deviation of 10. |
Week 4
|
PROMIS Pain interference, 8a (Follow-up)
Time Frame: Week 12
|
PROMIS Pain interference 8a assesses self-reported consequences of pain on relevant aspects of one's life in the past 7 days. The measure includes 8-items rating pain from "Not at all" = 1 to "Very much" = 5, therefore the response range is 8-40 with higher scores indicating greater pain interference. Item responses are combined to yield a standardized T-score with a mean of 50, and a standard deviation of 10. |
Week 12
|
Insomnia Severity Index, ISI (Endpoint)
Time Frame: Week 4
|
The Insomnia Severity Index is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia in the last month.
A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28.
The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
|
Week 4
|
Insomnia Severity Index, ISI (Follow-up)
Time Frame: Week 12
|
The Insomnia Severity Index is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia in the last month.
A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28.
The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
|
Week 12
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Suzanne Bertisch, MD, MPH, Assistant Professor in Medicine, Physician/Clinical Investigator
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2019P002027
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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