Improving Outcomes for Patients With SDB and Insufficient Sleep

Hypertension Clinical Trial

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Official title:

Improving Outcomes for Patients With SDB and Insufficient Sleep

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04279834
• Other study ID #: 1809001759
• Secondary ID: R01HL146059
• Status: Recruiting
• Phase: N/A
• Start date: October 16, 2020
• Est. completion date: July 31, 2024

Study information

• Verified date: September 2023
• Source: Wayne State University
• Contact: M. Safwan Badr, MD, MBA
• Phone: 3137452038
• Email: sbadr[@]med.wayne.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 495
• Est. completion date: July 31, 2024
• Est. primary completion date: April 6, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Insufficient Sleep Syndrome
• Sleep
• Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Deprivation

Intervention

Behavioral:
• PAP Treatment
Motivational enhancement plus remote-monitoring and participant self-monitoring of PAP use.
• Sleep Education I
Motivational enhancement plus participant self-monitoring of sleep.

Locations

Country	Name	City	State
United States	Wayne State University	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Wayne State University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3-months after randomization
Secondary	Reactive hyperemia index	Endothelial function will be measured by peripheral arterial tonometry (PAT) collected by fingertip sensor. Proprietary software is used to calculate a reactive hyperemia index.	3-months after randomization
Secondary	24-hours Ambulatory Blood Pressure	Blood pressure will be monitored over a 24-hour period. Mean 24-hour blood pressure, mean daytime (6am - 10pm), and mean nocturnal (10pm - 6am) blood pressure will be calculated.	3-months after randomization
Secondary	Fatigue Severity Scale (FSS)	The Fatigue Severity Scale (FSS) is a 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. Answers are scored on a point scale of 1 to 7 from strongly disagree to strongly agree. The minimum possible score is 9 and highest score is 63. A higher score indicates more severe fatigue and impact on the person's activities.	3-months after randomization
Secondary	Psychomotor Vigilance Test (PVT)	PVT is a performance measure of alertness and vigilance. Reaction time to a visual cue, delivered at random intervals varying from 2 to 10 seconds, is measured. The total number of lapses (reaction time >500ms) during the 10 minute test will be used as a measure of objective alertness.	3-months after randomization