Trial Outcomes & Findings for Brain Oxygenation and Hemodynamics During Sleep in Obstructive Sleep Apnea Sufferers (NCT NCT00591591)

NCT ID: NCT00591591

Last Updated: 2011-03-16

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 309 participants
• Primary outcome timeframe: 6 hours of sleep
• Results posted on: 2011-03-16

Participant Flow

OSAS sufferers and Controls have been recruited an tested at: 1. Center of Sleep Disorders of the University of Illinois at Chicago. 2. Regional Sleep Disorders Center at Carle Foundation Hospital (Urbana,IL). 3. University of California-Irvine Medical Center-Center for Sleep Disorders (UCIMC) 4. Stanford University -Sleep Disorders Clinic

Participant milestones

Measure	Controls Healthy controls	Obsructive Sleep Apnea Sufferers Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome
Overall Study STARTED	176	133
Overall Study COMPLETED	165	94
Overall Study NOT COMPLETED	11	39

Reasons for withdrawal

Measure	Controls Healthy controls	Obsructive Sleep Apnea Sufferers Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome
Overall Study Withdrawal by Subject	1	37
Overall Study Lack of Efficacy	10	2

Baseline Characteristics

Brain Oxygenation and Hemodynamics During Sleep in Obstructive Sleep Apnea Sufferers

Baseline characteristics by cohort

Measure	Controls n=176 Participants Healthy controls	Obsructive Sleep Apnea Sufferers n=133 Participants Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome	Total n=309 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	176 Participants n=5 Participants	133 Participants n=7 Participants	309 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	34.9 years STANDARD_DEVIATION 10.15 • n=5 Participants	41.7 years STANDARD_DEVIATION 8.9 • n=7 Participants	38.3 years STANDARD_DEVIATION 9.52 • n=5 Participants
Sex: Female, Male Female	111 Participants n=5 Participants	86 Participants n=7 Participants	197 Participants n=5 Participants
Sex: Female, Male Male	65 Participants n=5 Participants	47 Participants n=7 Participants	112 Participants n=5 Participants
Region of Enrollment United States	176 participants n=5 Participants	133 participants n=7 Participants	309 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 hours of sleep

Population: Absolute Brain Oximetry: Quantitative Hemodynamic Responses of Brain During Sleep, in Healthy \& OSA Subjects.

Outcome measures

Measure	Controls n=176 Participants Healthy controls	Obsructive Sleep Apnea Sufferers n=133 Participants Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome
Percentage of Oxygen Saturation in the Brain During Sleep	53.462 Percentage of brain oxygen saturation Standard Deviation 8.825	53.13 Percentage of brain oxygen saturation Standard Deviation 11.24

PRIMARY outcome

Timeframe: 6 hours of sleep

Population: Absolute Brain Oximetry: Quantitative Hemodynamic Responses of Brain During Sleep, in Healthy \& OSA Subjects.

Outcome measures

Measure	Controls n=176 Participants Healthy controls	Obsructive Sleep Apnea Sufferers n=133 Participants Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome
Oxyhemoglobin Concentration in the Brain During Sleep	18.82 µM Standard Deviation 7.81	18.36 µM Standard Deviation 7.96

PRIMARY outcome

Timeframe: 6 hours of sleep

Outcome measures

Measure	Controls n=176 Participants Healthy controls	Obsructive Sleep Apnea Sufferers n=133 Participants Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome
Total Hemoglobin Concentration in the Brain During Sleep	34.38 µM Standard Deviation 11.72	33.71 µM Standard Deviation 11.22

PRIMARY outcome

Timeframe: 6 hours of sleep

Population: Absolute Brain Oximetry: Quantitative Hemodynamic Responses of Brain During Sleep, in Healthy \& OSA Subjects.

Outcome measures

Measure	Controls n=176 Participants Healthy controls	Obsructive Sleep Apnea Sufferers n=133 Participants Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome
Deoxy-Hemoglobin Concentration in the Brain During Sleep	15.82 µM Standard Deviation 6.73	15.41 µM Standard Deviation 4.71

SECONDARY outcome

Timeframe: 6 hours of sleep

Outcome measures

Measure	Controls n=176 Participants Healthy controls	Obsructive Sleep Apnea Sufferers n=133 Participants Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome
Apnea Hypopnea Index (AHI is the Index of Severity That Combines Apneas and Hypopneas) Determined During the Routine Sleep Study	1.78 Number of apnea/hypopnea per sleep hour Standard Deviation 2.41	42.4 Number of apnea/hypopnea per sleep hour Standard Deviation 32.6

Adverse Events

Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Obsructive Sleep Apnea Sufferers

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

Antonios Michalos

ISS, Inc., Champaign Illinois

Phone: 217-359-8681

Email: antonios.michalos@iss.com

Results disclosure agreements

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