Reports on Sleep Quality and Thermoregulation Among Veterans

NCT04236661 | Withdrawn FDA Device

• 1 other identifier: New Chilipad
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

To assess and compare the quality of sleep self- reported by veterans with sleep disorders before and after use of the Chilipad cooling mattress pad

Conditions

Sleep Disturbance

Keywords

chilipad; Sleep disorders

Outcome Measures

Primary Outcomes (2)

• PROMIS Sleep Related Impairment Short Form

  PROMIS sleep related impairment short form is a questionnaire with 8-item 5-point Likert rating scale survey reflecting DSM-5 for sleep disturbance. The raw score on 8 items is determined, summed for a raw score, then a T-score table is utilized to compare with the subject's individual score. The result, rounded to the nearest whole number determines the score. The survey T-scores are interpreted as: \< 55 = none to slight; 55.0 - 59.9 = mild; 60.0 - 69.9 = moderate; and \> 70 = severe

  5-week prior intervention

• PROMIS Sleep Related Impairment Short Form

  PROMIS sleep related impairment short form is a questionnaire with 8-item 5-point Likert rating scale survey reflecting DSM-5 for sleep disturbance. The raw score on 8 items is determined, summed for a raw score, then a T-score table is utilized to compare with the subject's individual score. The result, rounded to the nearest whole number determines the score. The survey T-scores are interpreted as: \< 55 = none to slight; 55.0 - 59.9 = mild; 60.0 - 69.9 = moderate; and \> 70 = severe

  5-week after intervention

Secondary Outcomes (11)

• OURA ring total sleep metric

  Nightly for 5 weeks

• OURA ring REM metric

  Nightly for 5 weeks

• OURA ring DEEP sleep metric

  Nightly for 5 weeks

• OURA ring Efficiency metric

  Nightly for 5 weeks

• OURA ring latency metric

  Nightly for 5 weeks

Study Arms (1)

Chilipad Arm

EXPERIMENTAL

Subjects will use chilipad nightly for 5 weeks

Device: chilipad

Interventions

chilipad DEVICE

Chilipad is a commercially available pad designed to be placed between the top of a mattress and bed sheets. It allows for precise temperature regulation in one's bed.

Chilipad Arm

Eligibility Criteria

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

You may qualify if:

• Adult male and female veteran patients (\> 18 years of age)
• Self-report of sleep disturbance, defined as "sleep of poor quality, timing, efficiency, or duration"

You may not qualify if:

• Non-adult patients \< 18 years of age.
• Patients with chart documentation or self-report of illegal drug use, impaired orientation and cognition or currently incarcerated.
• Initiated CAM or non-CAM treatments for sleep disturbance in the last 4 weeks.
• Changed dose of a CAM or non-CAM treatments for sleep disturbance in the last 4 weeks.
• Initiated antidepressants in the last 3 months.
• Changed of an antidepressant in the last 3 months.
• Patients who describe their health as fair or poor.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

Related Links

• describes oura ring outcome measures in detail

MeSH Terms

Conditions

Parasomnias; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Remy Coeytaux, MD, PhD

  Wake Forest University Health Sciences

  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: SPONSOR

Model Details: Twenty subjects with self-reporting sleep disturbance will use the Chilipad cooling mattress for 5 weeks. The subjects will be given a Diary to complete tracking sleep quality during the 5 weeks. Subjects will also be given questionnaires before and after the sleep study part of the study to measure changes

Study Record Dates

• First Submitted: January 17, 2020
• First Posted: January 22, 2020
• Study Start: July 1, 2020
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: August 7, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)