Improving Outcomes for Patients With SDB and Insufficient Sleep

Wayne State University558 enrolled

Overview

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.

Sleep disordered breathing (SDB) is associated with significant adverse health consequences including cardiovascular disease, motor vehicle accidents, daytime functional impairments, and mortality risk. A significant proportion of the populace has mild to moderate SDB. This study is a randomized control trial (RCT) to test the efficacy of a program combining patient monitoring with behavioral techniques across Positive Airway Pressure (PAP) and sleep education. Screening for sleep apnea will be performed based on a phone screening questionnaire and an initial polysomnography (collected from another clinic or collected by research staff). Both objective (actigraphy, Psychomotor Vigilance Test, 24 hour blood pressure monitoring, office blood pressure, and EndoPATTM) and self-report (questionnaire/diary) sleep measures will be collected, as well as other health-related measures. Participants with an Apnea Hypopnea Index (AHI) between 5 and 30, and who meet all inclusion/exclusion criteria will be randomized to one of two educational programs. Both groups will receive education about SDB and sleep, but only one group will receive PAP devices. This information will be provided to participants as part of the 4-session intervention. Follow-up assessments will be conducted immediately following the intervention and after 3-months. Main study outcomes (lapses, daytime sleepiness, endothelial function and ambulatory blood pressure) will be assessed at baseline, post treatment and 3 month. Data will be analyzed using "intention to treat" principles, and appropriate statistical methods for clinical trials.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

558

Conditions

Sleep Apnea Insufficient Sleep Syndrome Sleep Hypertension

Interventions

PAP TreatmentBEHAVIORAL

Motivational enhancement plus remote-monitoring and participant self-monitoring of PAP use.

Sleep Education IBEHAVIORAL

Motivational enhancement plus participant self-monitoring of sleep.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Wayne State University

Detroit, Michigan, United States

Outcomes

Primary Outcomes

Epworth Sleepiness Scale (ESS)

ESS is an 8-item questionnaire that assesses general level of daytime sleepiness. Total score ranges from 0 - 24, with higher scores indicating greater sleepiness.