Improving Outcomes for Patients With SDB and Insufficient Sleep
The purpose of this study is to look at how sleep disordered breathing (SDB) and not getting enough sleep each night contribute to daytime sleepiness. The investigators also want to determine the treatment that works best for improving daytime sleepiness. In this study, the investigators are comparing 2 programs that may improve symptoms of daytime sleepiness.
Conditions:
🦠 Sleep Apnea 🦠 Insufficient Sleep Syndrome 🦠 Sleep 🦠 Hypertension
🗓️ Study Start (Actual) 16 October 2020
🗓️ Primary Completion (Estimated) 6 May 2025
✅ Study Completion (Estimated) 31 July 2025
👥 Enrollment (Estimated) 495
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Detroit, Michigan, United States

📋 Eligibility Criteria

Description

  • Inclusion Criteria for enrollment are:
  • * Over age 18 years
  • * Diagnosed with mild to moderate sleep disordered breathing (SDB) (Apnea Hypopnea Index of 5-30)
  • Additional Inclusion Criteria for randomization will be:
  • * ESS score \>6
  • * Total sleep time \<7 hours at least 4 nights per week, based on baseline sleep diary.

Exclusion Criteria:

  • * Current use of PAP or oral appliance therapy for SDB
  • * Severe respiratory or cardiovascular disease (e.g., ventilatory failure, congestive heart failure)
  • * A recent health event that may affect sleep (e.g. recent surgery or hospitalization)
  • * Current alcohol or substance use disorder (\<90 days sobriety) or significant unstable psychiatric comorbidity (e.g., suicidal ideation, psychosis)
  • * Pregnancy or within 6 months post-partum
  • * Commercial drivers and individuals at risk for motor vehicle accidents (MVA) or ESS\>18
  • * Significant comorbid sleep disorders (e.g., severe insomnia, narcolepsy); and
  • * Central sleep apnea (defined as central apnea/hypopnea index \>5, and \>50% of total AHI).
  • * Use of sedative-hypnotic medications higher than the maximal acceptable therapeutic dose range.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 19 February 2020
  • First Submitted that Met QC Criteria 19 February 2020
  • First Posted 21 February 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 23 July 2024
  • Last Update Posted 24 July 2024
  • Last Verified July 2024