Trial Outcomes & Findings for Metabolic Study of Sleep Apnea in Men and Women (NCT NCT00706511)

NCT ID: NCT00706511

Last Updated: 2020-03-24

Results Overview

apnea-hypopnea index: number of apneas and hypopneas per hour of recording; a measure of the severity of obstructive sleep apnea; varies from min=0 to max=120; AHI between 0 and \<5: no significant sleep apnea; AHI between 5 and \<15: mild sleep apnea; AHI between 15 and \<30: moderate sleep apnea; AHI of 30 and above: severe sleep apnea.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 27 participants
• Primary outcome timeframe: After 6 weeks of CPAP (Treatment)
• Results posted on: 2020-03-24

Participant Flow

Participant milestones

Measure	Men With OSA Obese men and pre-menopausal women with OSA will receive 6 weeks of CPAP treatment, and assessed with a 3-day experimental protocol. CPAP: CPAP (continuous positive airway pressure) treatment at home for 6 weeks	Women With OSA Obese men and pre-menopausal women with OSA will receive 6 weeks of CPAP treatment, and assessed with a 3-day experimental protocol. CPAP: CPAP (continuous positive airway pressure) treatment at home for 6 weeks	Men Without OSA Obese men and pre-menopausal women without OSA will be characterized with a single 3-day experimental protocol	Women Without OSA Obese men and pre-menopausal women without OSA will be characterized with a single 3-day experimental protocol
Overall Study STARTED	10	4	3	10
Overall Study COMPLETED	9	4	3	10
Overall Study NOT COMPLETED	1	0	0	0

Reasons for withdrawal

Measure	Men With OSA Obese men and pre-menopausal women with OSA will receive 6 weeks of CPAP treatment, and assessed with a 3-day experimental protocol. CPAP: CPAP (continuous positive airway pressure) treatment at home for 6 weeks	Women With OSA Obese men and pre-menopausal women with OSA will receive 6 weeks of CPAP treatment, and assessed with a 3-day experimental protocol. CPAP: CPAP (continuous positive airway pressure) treatment at home for 6 weeks	Men Without OSA Obese men and pre-menopausal women without OSA will be characterized with a single 3-day experimental protocol	Women Without OSA Obese men and pre-menopausal women without OSA will be characterized with a single 3-day experimental protocol
Overall Study Withdrawal by Subject	1	0	0	0

Baseline Characteristics

Metabolic Study of Sleep Apnea in Men and Women

Baseline characteristics by cohort

Measure	Men With OSA n=10 Participants Obese men and pre-menopausal women with OSA will receive 6 weeks of CPAP treatment, and assessed with a 3-day experimental protocol. CPAP: CPAP (continuous positive airway pressure) treatment at home for 6 weeks	Women With OSA n=4 Participants Obese men and pre-menopausal women with OSA will receive 6 weeks of CPAP treatment, and assessed with a 3-day experimental protocol. CPAP: CPAP (continuous positive airway pressure) treatment at home for 6 weeks	Men Without OSA n=3 Participants Obese men and pre-menopausal women without OSA will be characterized with a single 3-day experimental protocol	Women Without OSA n=10 Participants Obese men and pre-menopausal women without OSA will be characterized with a single 3-day experimental protocol	Total n=27 Participants Total of all reporting groups
Age, Continuous	37.7 years STANDARD_DEVIATION 6.5 • n=5 Participants	35 years STANDARD_DEVIATION 2.9 • n=7 Participants	24.7 years STANDARD_DEVIATION 1.5 • n=5 Participants	31.9 years STANDARD_DEVIATION 7.4 • n=4 Participants	33.7 years STANDARD_DEVIATION 7.2 • n=21 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	10 Participants n=4 Participants	14 Participants n=21 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	13 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants	15 Participants n=21 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	12 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants

PRIMARY outcome

Timeframe: After 6 weeks of CPAP (Treatment)

Population: One participant (a men with OSA) was excluded in the analysis because he did not complete the study. (See the participant flow chart)

apnea-hypopnea index: number of apneas and hypopneas per hour of recording; a measure of the severity of obstructive sleep apnea; varies from min=0 to max=120; AHI between 0 and <5: no significant sleep apnea; AHI between 5 and <15: mild sleep apnea; AHI between 15 and <30: moderate sleep apnea; AHI of 30 and above: severe sleep apnea.

Outcome measures

Measure	Men With OSA n=9 Participants Obese men and pre-menopausal women with OSA will receive 6 weeks of CPAP treatment, and assessed with a 3-day experimental protocol. CPAP: CPAP (continuous positive airway pressure) treatment at home for 6 weeks	Women With OSA n=4 Participants Obese men and pre-menopausal women with OSA will receive 6 weeks of CPAP treatment, and assessed with a 3-day experimental protocol. CPAP: CPAP (continuous positive airway pressure) treatment at home for 6 weeks	Men Without OSA n=3 Participants Obese men and pre-menopausal women without OSA will be characterized with a single 3-day experimental protocol	Women Without OSA n=10 Participants Obese men and pre-menopausal women without OSA will be characterized with a single 3-day experimental protocol
Polysomnography - Apnea-hypopnea Index (AHI)	11.4 units on a scale Standard Deviation 13.7	0.7 units on a scale Standard Deviation 0.8	6 units on a scale Standard Deviation 5.2	1.1 units on a scale Standard Deviation 1.5

PRIMARY outcome

Timeframe: After 6 weeks of CPAP (Treatment)

Population: One participant (a men with OSA) was excluded in the analysis because he did not complete the study. (See the participant flow chart)

Stage N3, sometimes referred to as "delta sleep" or "slow wave sleep", is characterized by slow waves in the electro-encephalogram (EEG) that reflect synchronization of firing of cortical neurons. N3 sleep is considered the most restorative stage of sleep for both the brain and the rest of the body.

Outcome measures

Measure	Men With OSA n=9 Participants Obese men and pre-menopausal women with OSA will receive 6 weeks of CPAP treatment, and assessed with a 3-day experimental protocol. CPAP: CPAP (continuous positive airway pressure) treatment at home for 6 weeks	Women With OSA n=4 Participants Obese men and pre-menopausal women with OSA will receive 6 weeks of CPAP treatment, and assessed with a 3-day experimental protocol. CPAP: CPAP (continuous positive airway pressure) treatment at home for 6 weeks	Men Without OSA n=3 Participants Obese men and pre-menopausal women without OSA will be characterized with a single 3-day experimental protocol	Women Without OSA n=10 Participants Obese men and pre-menopausal women without OSA will be characterized with a single 3-day experimental protocol
Polysomnography - Minutes of N3 Stage	58.1 minutes Standard Deviation 42.6	53.7 minutes Standard Deviation 28.7	75.7 minutes Standard Deviation 22.4	66.6 minutes Standard Deviation 30.6

PRIMARY outcome

Timeframe: After 6 weeks of CPAP (Treatment)

Population: One participant (a men with OSA) was excluded in the analysis because he did not complete the study. (See the participant flow chart)

Outcome measures

Measure	Men With OSA n=9 Participants Obese men and pre-menopausal women with OSA will receive 6 weeks of CPAP treatment, and assessed with a 3-day experimental protocol. CPAP: CPAP (continuous positive airway pressure) treatment at home for 6 weeks	Women With OSA n=4 Participants Obese men and pre-menopausal women with OSA will receive 6 weeks of CPAP treatment, and assessed with a 3-day experimental protocol. CPAP: CPAP (continuous positive airway pressure) treatment at home for 6 weeks	Men Without OSA n=3 Participants Obese men and pre-menopausal women without OSA will be characterized with a single 3-day experimental protocol	Women Without OSA n=10 Participants Obese men and pre-menopausal women without OSA will be characterized with a single 3-day experimental protocol
Polysomnography - Minutes of REM Stage	98.2 minutes Standard Deviation 24.1	101.5 minutes Standard Deviation 10.9	107.8 minutes Standard Deviation 28.2	111.1 minutes Standard Deviation 24.1

PRIMARY outcome

Timeframe: After 6 weeks of CPAP (Treatment)

Population: One participant (a men with OSA) was excluded in the analysis because he did not complete the study. (See the participant flow chart)

Sleep efficiency: a measure of objective sleep quality; calculated from the polygraphic sleep recording as the ratio of time spent asleep during the scheduled sleep period to total scheduled sleep period. Expressed in %. Varies from 0% (the subject did not sleep at all) to 100% (the subject spent the entire scheduled sleep period asleep).

Outcome measures

Measure	Men With OSA n=9 Participants Obese men and pre-menopausal women with OSA will receive 6 weeks of CPAP treatment, and assessed with a 3-day experimental protocol. CPAP: CPAP (continuous positive airway pressure) treatment at home for 6 weeks	Women With OSA n=4 Participants Obese men and pre-menopausal women with OSA will receive 6 weeks of CPAP treatment, and assessed with a 3-day experimental protocol. CPAP: CPAP (continuous positive airway pressure) treatment at home for 6 weeks	Men Without OSA n=3 Participants Obese men and pre-menopausal women without OSA will be characterized with a single 3-day experimental protocol	Women Without OSA n=10 Participants Obese men and pre-menopausal women without OSA will be characterized with a single 3-day experimental protocol
Polysomnography - Sleep Efficiency	88.9 score on a scale Standard Deviation 6.2	89.9 score on a scale Standard Deviation 6.5	86.5 score on a scale Standard Deviation 6.3	89.7 score on a scale Standard Deviation 5

SECONDARY outcome

Timeframe: After treatment (6 weeks)

Population: One participant (a men with OSA) was excluded in the analysis because he did not complete the study. (See the participant flow chart)

Sensitivity Index (SI): a measure of how much insulin the body needs to metabolize a given amount of glucose. SI is calculated using a mathematical model describing the profiles of blood glucose and serum insulin after intravenous glucose injection. SI varies from 0 to an undefined upper limit but generally under 20. Higher values of SI represent a better outcome.

Outcome measures

Measure	Men With OSA n=9 Participants Obese men and pre-menopausal women with OSA will receive 6 weeks of CPAP treatment, and assessed with a 3-day experimental protocol. CPAP: CPAP (continuous positive airway pressure) treatment at home for 6 weeks	Women With OSA n=4 Participants Obese men and pre-menopausal women with OSA will receive 6 weeks of CPAP treatment, and assessed with a 3-day experimental protocol. CPAP: CPAP (continuous positive airway pressure) treatment at home for 6 weeks	Men Without OSA n=3 Participants Obese men and pre-menopausal women without OSA will be characterized with a single 3-day experimental protocol	Women Without OSA n=10 Participants Obese men and pre-menopausal women without OSA will be characterized with a single 3-day experimental protocol
IVGTT (Intravenous Tolerance Test) - Sensitivity Index (SI)	1.226 score on a scale Standard Deviation 0.642	1.106 score on a scale Standard Deviation 0.44	2.32 score on a scale Standard Deviation 1.15	4.195 score on a scale Standard Deviation 3.346

SECONDARY outcome

Timeframe: After treatment (6 weeks)

Population: One participant (a men with OSA) was excluded in the analysis because he did not complete the study. (See the participant flow chart)

Acute Insulin Response is calculated as the area under the insulin curve for the first 19 minutes after intravenous glucose injection. "Area under the insulin curve" is expressed in pmol x min/L.

Outcome measures

Measure	Men With OSA n=9 Participants Obese men and pre-menopausal women with OSA will receive 6 weeks of CPAP treatment, and assessed with a 3-day experimental protocol. CPAP: CPAP (continuous positive airway pressure) treatment at home for 6 weeks	Women With OSA n=4 Participants Obese men and pre-menopausal women with OSA will receive 6 weeks of CPAP treatment, and assessed with a 3-day experimental protocol. CPAP: CPAP (continuous positive airway pressure) treatment at home for 6 weeks	Men Without OSA n=3 Participants Obese men and pre-menopausal women without OSA will be characterized with a single 3-day experimental protocol	Women Without OSA n=10 Participants Obese men and pre-menopausal women without OSA will be characterized with a single 3-day experimental protocol
IVGTT (Intravenous Tolerance Test) - Acute Insulin Response	1061 pmol x min/L Standard Deviation 736	623 pmol x min/L Standard Deviation 338	734 pmol x min/L Standard Deviation 784	1020 pmol x min/L Standard Deviation 564

SECONDARY outcome

Timeframe: After treatment (6 weeks)

Population: One participant (a men with OSA) was excluded in the analysis because he did not complete the study. (See the participant flow chart)

Disposition Index (DI) is the product of sensitivity index (SI) by the amount of insulin secreted in response to blood glucose levels. It is a marker of the risk of type 2 diabetes. Low DI reflects a high risk of diabetes. DI can vary from 0 to an undefined upper limit. The physiological range for the Disposition Index is 500 to 5,000. Higher values represent a better outcome.

Outcome measures

Measure	Men With OSA n=9 Participants Obese men and pre-menopausal women with OSA will receive 6 weeks of CPAP treatment, and assessed with a 3-day experimental protocol. CPAP: CPAP (continuous positive airway pressure) treatment at home for 6 weeks	Women With OSA n=4 Participants Obese men and pre-menopausal women with OSA will receive 6 weeks of CPAP treatment, and assessed with a 3-day experimental protocol. CPAP: CPAP (continuous positive airway pressure) treatment at home for 6 weeks	Men Without OSA n=3 Participants Obese men and pre-menopausal women without OSA will be characterized with a single 3-day experimental protocol	Women Without OSA n=10 Participants Obese men and pre-menopausal women without OSA will be characterized with a single 3-day experimental protocol
IVGTT (Intravenous Tolerance Test) - Disposition Index (DI)	1159 score on a scale Standard Deviation 789	683 score on a scale Standard Deviation 531	1257 score on a scale Standard Deviation 849	3718 score on a scale Standard Deviation 3270

Adverse Events

Group With OSA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group Without 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

Adverse event data not reported

Additional Information

Eve Van Cauter, PhD

University of Chicago

Phone: 773-702-0169

Email: evcauter@bsd.uchicago.edu

Results disclosure agreements

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