Trial Outcomes & Findings for Obstructive Sleep Apnea Endotypes and Impact on Phenotypes of People Living With HIV (NCT NCT03575143)

NCT ID: NCT03575143

Last Updated: 2023-08-21

Results Overview

The Psychomotor Vigilance Task (PVT) is commonly used to asses the impact of sleep (or sleep deprivation) on cognitive performance. Subjects are instructed to respond (by tapping a key on a keyboard) as fast as possible to a graphical stimulus displayed on a computer screen. The stimulus is presented multiple times at variable intervals every few seconds for 10 minutes. The reaction time is the mean latency from appearance of the stimulus to the response by the participant. Higher values suggest a slower reaction time compared to lower values.

• Recruitment status: COMPLETED
• Target enrollment: 132 participants
• Primary outcome timeframe: 1 day
• Results posted on: 2023-08-21

Participant Flow

Subjects living with HIV were enrolled after written informed consent was obtained. Enrolled subjects completed daytime questionnaires, 1 week of actigraphy, and then an overnight sleep study. Enrolled subjects were placed into 3 different groups: 1) those with OSA (based on Medicare Criteria 4%)(PLWH+OSA), 2) those without OSA (PLWH-OSA), and 3) those who did not complete overnight testing (PLWH?OSA).

Participant milestones

Measure	PLWH+OSA Subjects diagnosed with both Human Immunodeficiency Virus and Obstructive Sleep Apnea	PLWH-OSA Subjects diagnosed with both Human Immunodeficiency Virus without Obstructive Sleep Apnea	PLWH?OSA Those who signed consent but did not complete all the baseline assessments and overnight sleep study
Overall Study STARTED	66	55	11
Overall Study COMPLETED	66	55	0
Overall Study NOT COMPLETED	0	0	11

Reasons for withdrawal

Measure	PLWH+OSA Subjects diagnosed with both Human Immunodeficiency Virus and Obstructive Sleep Apnea	PLWH-OSA Subjects diagnosed with both Human Immunodeficiency Virus without Obstructive Sleep Apnea	PLWH?OSA Those who signed consent but did not complete all the baseline assessments and overnight sleep study
Overall Study Lost to Follow-up	0	0	4
Overall Study Withdrawal by Subject	0	0	5
Overall Study new information provide after consent, no longer met inclusion criteria	0	0	2

Baseline Characteristics

Subjects in the PLWH?OSA arm did not complete the baseline polysomnogram used to measure the apnea hypopnea index (3 or 4%).

Baseline characteristics by cohort

Measure	PLWH+OSA n=66 Participants Subjects diagnosed with both Human Immunodeficiency Virus and Obstructive Sleep Apnea	PLWH-OSA n=55 Participants Subjects diagnosed with both Human Immunodeficiency Virus without Obstructive Sleep Apnea	PLWH?OSA n=11 Participants Subjects diagnosed with HIV who signed consent but did not complete overnight sleep study	Total n=132 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=66 Participants	0 Participants n=55 Participants	0 Participants n=11 Participants	0 Participants n=132 Participants
Age, Categorical Between 18 and 65 years	66 Participants n=66 Participants	55 Participants n=55 Participants	11 Participants n=11 Participants	132 Participants n=132 Participants
Age, Categorical >=65 years	0 Participants n=66 Participants	0 Participants n=55 Participants	0 Participants n=11 Participants	0 Participants n=132 Participants
Sex: Female, Male Female	3 Participants n=66 Participants	15 Participants n=55 Participants	2 Participants n=11 Participants	20 Participants n=132 Participants
Sex: Female, Male Male	63 Participants n=66 Participants	40 Participants n=55 Participants	9 Participants n=11 Participants	112 Participants n=132 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=66 Participants	2 Participants n=55 Participants	0 Participants n=11 Participants	5 Participants n=132 Participants
Race (NIH/OMB) Asian	0 Participants n=66 Participants	1 Participants n=55 Participants	0 Participants n=11 Participants	1 Participants n=132 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=66 Participants	0 Participants n=55 Participants	0 Participants n=11 Participants	1 Participants n=132 Participants
Race (NIH/OMB) Black or African American	10 Participants n=66 Participants	9 Participants n=55 Participants	3 Participants n=11 Participants	22 Participants n=132 Participants
Race (NIH/OMB) White	44 Participants n=66 Participants	32 Participants n=55 Participants	6 Participants n=11 Participants	82 Participants n=132 Participants
Race (NIH/OMB) More than one race	6 Participants n=66 Participants	10 Participants n=55 Participants	2 Participants n=11 Participants	18 Participants n=132 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=66 Participants	1 Participants n=55 Participants	0 Participants n=11 Participants	3 Participants n=132 Participants
Apnea Hypopnea Index (4%)	32 events/hr STANDARD_DEVIATION 23 • n=66 Participants • Subjects in the PLWH?OSA arm did not complete the baseline polysomnogram used to measure the apnea hypopnea index (3 or 4%).	2 events/hr STANDARD_DEVIATION 2 • n=55 Participants • Subjects in the PLWH?OSA arm did not complete the baseline polysomnogram used to measure the apnea hypopnea index (3 or 4%).	—	19 events/hr STANDARD_DEVIATION 23 • n=121 Participants • Subjects in the PLWH?OSA arm did not complete the baseline polysomnogram used to measure the apnea hypopnea index (3 or 4%).
Apnea Hypopnea Index (3%)	42 events/hr STANDARD_DEVIATION 24 • n=66 Participants • Subjects in the PLWH?OSA arm did not complete the baseline polysomnogram used to measure the apnea hypopnea index (3 or 4%).	7 events/hr STANDARD_DEVIATION 6 • n=55 Participants • Subjects in the PLWH?OSA arm did not complete the baseline polysomnogram used to measure the apnea hypopnea index (3 or 4%).	—	26 events/hr STANDARD_DEVIATION 25 • n=121 Participants • Subjects in the PLWH?OSA arm did not complete the baseline polysomnogram used to measure the apnea hypopnea index (3 or 4%).

PRIMARY outcome

Timeframe: 1 day

The Psychomotor Vigilance Task (PVT) is commonly used to asses the impact of sleep (or sleep deprivation) on cognitive performance. Subjects are instructed to respond (by tapping a key on a keyboard) as fast as possible to a graphical stimulus displayed on a computer screen. The stimulus is presented multiple times at variable intervals every few seconds for 10 minutes. The reaction time is the mean latency from appearance of the stimulus to the response by the participant. Higher values suggest a slower reaction time compared to lower values.

Outcome measures

Measure	PLWH+OSA+High AT n=35 Participants Subjects diagnosed with both Human Immunodeficiency Virus and Obstructive Sleep Apnea with a High arousal threshold	PLWH+OSA+Low AT n=24 Participants Subjects diagnosed with both Human Immunodeficiency Virus and Obstructive Sleep Apnea with a Low Arousal Threshold	PLWH-OSA n=51 Participants Subjects diagnosed with Human Immunodeficiency Virus without Obstructive Sleep Apnea
Reaction Time Measured Using the Psychomotor Vigilance Task	346 ms Standard Deviation 38	353 ms Standard Deviation 39	348 ms Standard Deviation 48

SECONDARY outcome

Timeframe: 1 day

Population: A loop gain of .7 was used as a cutoff between Low and High LG groups

Reactive hyperemia is measured using the commercially available EndoPAT device (Itamar Medical). Briefly, the device uses finger plethysmography to measure the finger arterial pulse wave amplitude. Subjects have the pulse wave measured during rest, during the application of a blood pressure cuff to occlude blood flow for 5 minutes, and then once the blood pressure cuff is deflated. The reactive hyperemia index (RHI) is the ratio (thus dimensionless) of the pulse wave amplitude after occlusion compared to the pre-occlusion value. Values for the RHI are physiologically greater than 1 (least health endothelial function), with the highest values in the literature about 3. (See Itzhaki SLEEP 2005;28(5):594-600.) Higher ratios are considered to reflect healthier endothelial function.

Outcome measures

Measure	PLWH+OSA+High AT n=37 Participants Subjects diagnosed with both Human Immunodeficiency Virus and Obstructive Sleep Apnea with a High arousal threshold	PLWH+OSA+Low AT n=22 Participants Subjects diagnosed with both Human Immunodeficiency Virus and Obstructive Sleep Apnea with a Low Arousal Threshold	PLWH-OSA Subjects diagnosed with Human Immunodeficiency Virus without Obstructive Sleep Apnea
Reactive Hyperemia Index (RHI) Assessed by Peripheral Arterial Tonometry	1.6 ratio (unitless) Standard Deviation .38	1.52 ratio (unitless) Standard Deviation .36	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

To test in PLWH+OSA whether 3 months of PAP treatment results in changes in OSA manifestations. This aim will allow us to test the hypothesis that endotype underlying OSA will be predictive of the specific clinical improvements seen in adherent users of PAP therapy. For example, those with high LG at baseline will have the greatest improvement in endothelial dysfunction with PAP therapy compared to other OSA patients with similar disease severity as measured by AHI.

Outcome measures

Outcome data not reported

Adverse Events

PLWH+OSA

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

PLWH-OSA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PLWH?OSA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	PLWH+OSA n=66 participants at risk Subjects diagnosed with both Human Immunodeficiency Virus and Obstructive Sleep Apnea	PLWH-OSA n=55 participants at risk Subjects diagnosed with both Human Immunodeficiency Virus without Obstructive Sleep Apnea	PLWH?OSA n=11 participants at risk Those who signed consent but did not complete all the baseline assessments and overnight sleep study
Skin and subcutaneous tissue disorders Epistaxis	1.5% 1/66 • Number of events 1 • Duration of participation in the study, which varied according to each study participant. Those subjects who were PLWH-OSA completed the study generally in 7-10 days. Subjects who were PLWH+OSA completed an additional overnight sleep study and then used CPAP therapy for 12 weeks. Their participation in the study might be up to 6 months depending on the timing of procedures.	0.00% 0/55 • Duration of participation in the study, which varied according to each study participant. Those subjects who were PLWH-OSA completed the study generally in 7-10 days. Subjects who were PLWH+OSA completed an additional overnight sleep study and then used CPAP therapy for 12 weeks. Their participation in the study might be up to 6 months depending on the timing of procedures.	0.00% 0/11 • Duration of participation in the study, which varied according to each study participant. Those subjects who were PLWH-OSA completed the study generally in 7-10 days. Subjects who were PLWH+OSA completed an additional overnight sleep study and then used CPAP therapy for 12 weeks. Their participation in the study might be up to 6 months depending on the timing of procedures.

Additional Information

Robert L. Owens, MD

University of California San Diego

Phone: 8586575258

Email: rowens@health.ucsd.edu

Results disclosure agreements

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