Trial Outcomes & Findings for Memory Consolidation in Obstructive Sleep Apnea (NCT NCT01800786)

NCT ID: NCT01800786

Last Updated: 2017-06-06

Results Overview

At 3 months, we compared average overnight changes between evening and morning performance on a declarative memory test between untreated OSA subjects and those who received CPAP therapy for 3 months. Positive numbers represent an increase in performance.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 33 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2017-06-06

Participant Flow

Participant milestones

Measure	OSA-CPAP Group OSA patient will use CPAP for 3 months CPAP= continuous positive airway pressure therapy OSA= obstructive sleep apnea	OSA -no CPAP newly diagnosed OSA patient will not wear CPAP for 3 months
Overall Study STARTED	17	16
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Memory Consolidation in Obstructive Sleep Apnea

Baseline characteristics by cohort

Measure	OSA-CPAP Group n=17 Participants OSA patient will use CPAP for 3 months CPAP= continuous positive airway pressure therapy OSA= obstructive sleep apnea	OSA -no CPAP n=16 Participants newly diagnosed OSA patient will not wear CPAP for 3 months	Total n=33 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	17 Participants n=5 Participants	16 Participants n=7 Participants	33 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	48.7 years STANDARD_DEVIATION 12.4 • n=5 Participants	46.4 years STANDARD_DEVIATION 13 • n=7 Participants	47.9 years STANDARD_DEVIATION 12.6 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants	16 participants n=7 Participants	33 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

At 3 months, we compared average overnight changes between evening and morning performance on a declarative memory test between untreated OSA subjects and those who received CPAP therapy for 3 months.

Positive numbers represent an increase in performance.

Outcome measures

Measure	OSA-CPAP Group n=17 Participants OSA patient will use CPAP for 3 months CPAP= continuous positive airway pressure therapy OSA= obstructive sleep apnea	OSA -no CPAP n=16 Participants newly diagnosed OSA patient will not wear CPAP for 3 months
Overnight Change in Declarative Memory Performance	11.2 percent change in performance Standard Deviation 0.8	6.5 percent change in performance Standard Deviation 0.11

Adverse Events

OSA-CPAP Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

OSA -no CPAP

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

Ina Djonlagic

Brigham and Women's Hospital

Phone: 617 667 5129

Email: idjonlag@bidmc.harvard.edu

Results disclosure agreements

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