Trial Outcomes & Findings for Comparative Effectiveness Research to Enhance Outcomes in African-Americans With Obstructive Sleep Apnea (NCT NCT01997723)

NCT ID: NCT01997723

Last Updated: 2024-05-29

Results Overview

AHI is the number of abnormal respiratory events (apneas and hypopneas) per hour of sleep. AHI on home portable monitor (PM) compared to AHI on laboratory polysomnography (PSG).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 75 participants
• Primary outcome timeframe: 4 days
• Results posted on: 2024-05-29

Participant Flow

Participant milestones

Measure	Experimental Cross-over design, single group/arm Portable monitoring for OSA diagnosis: A device applied over 1 arm (on the wrist and finger), worn overnight by patients to detect OSA.
Overall Study STARTED	75
Overall Study COMPLETED	75
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparative Effectiveness Research to Enhance Outcomes in African-Americans With Obstructive Sleep Apnea

Baseline characteristics by cohort

Measure	OSA Testing n=75 Participants Cross-over design, single group/arm Interventions: One polysomnography one laboratory Portable monitoring simultaneously with polysomnography one home Portable monitoring
Age, Continuous	44 years STANDARD_DEVIATION 10.6 • n=5 Participants
Sex: Female, Male Female	57 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	75 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
employed	36 participants n=5 Participants
Household income less than $50,000 per year	57 participants n=5 Participants
Education less than or equal to high school	26 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 days

Population: The polysomnography area under the curve (AUC) in an ROC plot for this study was assumed to be 0.99. The AUC for home PM test was targeted at 0.88 based on published report for power of 0.90 in a population with estimated pretest probability of 75-85%, ascertained by Berlin Questionnaire.

AHI is the number of abnormal respiratory events (apneas and hypopneas) per hour of sleep.

AHI on home portable monitor (PM) compared to AHI on laboratory polysomnography (PSG).

Outcome measures

Measure	OSA Testing n=75 Participants Cross-over design, single group/arm Portable monitoring for OSA diagnosis: A device applied over 1 arm (on the wrist and finger), worn overnight by patients to detect OSA.
Apnea Hypopnea Index (AHI) Home Portable monitor AHI	32.3 events per hour Standard Deviation 27.6
Apnea Hypopnea Index (AHI) Polysomnography AHI	30.3 events per hour Standard Deviation 35
Apnea Hypopnea Index (AHI) Lab portable monitor AHI	39.1 events per hour Standard Deviation 29.1

SECONDARY outcome

Timeframe: 4 days

home PM tests that failed to provide technically adequate data for diagnosis. Technical failure(s) were tests where estimated total sleep time (TST) was ≤ 2 hours or portable monitor data of interpretable quality was less than 4 hours per recording.

Outcome measures

Measure	OSA Testing n=75 Participants Cross-over design, single group/arm Portable monitoring for OSA diagnosis: A device applied over 1 arm (on the wrist and finger), worn overnight by patients to detect OSA.
Technical Failure Rate Home PM	5.3 percentage of recordings
Technical Failure Rate Lab PM	3.1 percentage of recordings

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 week

The participants indicated if they preferred Home Testing or in-laboratory Testing.

Outcome measures

Measure	OSA Testing n=75 Participants Cross-over design, single group/arm Portable monitoring for OSA diagnosis: A device applied over 1 arm (on the wrist and finger), worn overnight by patients to detect OSA.
Percentage of Participants Who Prefer Home Testing Over Laboratory Testing	82 percentage of participants

Adverse Events

OSA Testing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Bharati Prasad

UIllinois

Phone: 3129968433

Email: bpradsad@uic.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place