Trial Outcomes & Findings for Cognitive Benefits of Treating Sleep Apnea in Parkinson's Disease (NCT NCT00492115)

NCT ID: NCT00492115

Last Updated: 2019-07-23

Results Overview

Overnight sleep studies were done to determine the effect of treatment on the apnea-hypopnea index (number of apneas and hypopneas per hour of sleep)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 98 participants
• Primary outcome timeframe: six weeks
• Results posted on: 2019-07-23

Participant Flow

Patients were referred to UCSD by community neurologists or volunteered after hearing a talk about the study at PD support group meetings.

183 contacted; 144 screened/phone; 106 consented, 5 dropped/12 excluded; 89 screened for apnea with sleep study (2 dropped during night study), 44 had no sleep apnea. 5 declined treatment. 19 participants randomized to each arm

Participant milestones

Measure	A: Continuous Positive Airway Pressure (CPAP) Continuous positive airway pressure (CPAP) Continuous positive airway pressure (CPAP): therapeutic CPAP for six weeks	B: Placebo Continuous Positive Airway Pressure Placebo Continuous Positive airway pressure Placebo CPAP: Ineffective CPAP 3 weeks placebo CPAP followed by 3 weeks of therapeutic CPAP
Overall Study STARTED	19	19
Overall Study COMPLETED	16	15
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Measure	A: Continuous Positive Airway Pressure (CPAP) Continuous positive airway pressure (CPAP) Continuous positive airway pressure (CPAP): therapeutic CPAP for six weeks	B: Placebo Continuous Positive Airway Pressure Placebo Continuous Positive airway pressure Placebo CPAP: Ineffective CPAP 3 weeks placebo CPAP followed by 3 weeks of therapeutic CPAP
Overall Study Withdrawal by Subject	3	4

Baseline Characteristics

Cognitive Benefits of Treating Sleep Apnea in Parkinson's Disease

Baseline characteristics by cohort

Measure	A: Continuous Positive Airway Pressure n=19 Participants Continuous Positive Airway Pressure (therapeutic CPAP) for 6 weeks	B. Sham CPAP n=19 Participants Sham (placebo) CPAP for 3 weeks followed by therapeutic CPAP for 3 weeks.	Total n=38 Participants Total of all reporting groups
Age, Continuous	66.7 years STANDARD_DEVIATION 8.5 • n=5 Participants	67.7 years STANDARD_DEVIATION 10.0 • n=7 Participants	67.2 years STANDARD_DEVIATION 9.3 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	14 Participants n=7 Participants	26 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants	19 participants n=7 Participants	38 participants n=5 Participants

PRIMARY outcome

Timeframe: six weeks

Overnight sleep studies were done to determine the effect of treatment on the apnea-hypopnea index (number of apneas and hypopneas per hour of sleep)

Outcome measures

Measure	A: Continuous Positive Airway Pressure (CPAP): n=17 Participants CPAP Continuous positive airway pressure (CPAP): therapeutic CPAP	B: Placebo CPAP: Ineffective CPAP n=15 Participants Placebo CPAP Placebo CPAP: Ineffective CPAP
Tests to Determine the Apnea-hypopnea Index (Number of Apneas and Hypopneas Per Hour of Sleep)	5.2 apnea hypopnea index Standard Deviation 2	20 apnea hypopnea index Standard Deviation 4

SECONDARY outcome

Timeframe: 6 weeks

Overnight sleep studies were done to examine the effect of CPAP treatment on sleep stages and on %time spent at Sa)2<90%.

Outcome measures

Measure	A: Continuous Positive Airway Pressure (CPAP): n=17 Participants CPAP Continuous positive airway pressure (CPAP): therapeutic CPAP	B: Placebo CPAP: Ineffective CPAP n=15 Participants Placebo CPAP Placebo CPAP: Ineffective CPAP
Sleep Stages; %Time Spent at SaO2<90%;	2.1 Percent time spent at low oxygen <90% Standard Deviation 1	12.9 Percent time spent at low oxygen <90% Standard Deviation 5

Adverse Events

A: Continuous Positive Airway Pressure (CPAP): Therapeutic CPA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

B: Placebo CPAP: Ineffective 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

Dr. Sonia Ancoli-Israel

UCSD

Phone: 858 822 7710

Email: sancoliisrael@ucsd.edu

Results disclosure agreements

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