Trial Outcomes & Findings for Effects of Treating Obstructive Sleep Apnea in Epilepsy (NCT NCT00047463)

Results Overview

This measure quantifies how well patients use their CPAP. The standard unit of measurement is proportion of nights that the CPAP is used by a participant (total nights used/total nights the device could have been used), averaged across all participants . Data were downloaded by a card placed in the CPAP machine reflecting use over the entire 10 weeks.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

68 participants

Primary outcome timeframe

10 weeks

Results posted on

2016-07-21

Participant Flow

This pilot clinical trial was conducted between September 2002 and July 2005 at University of Michigan, Cleveland Clinic, University of North Carolina at Chapel Hill, and Vanderbilt University, with a Data Coordinating Center at the University of Michigan. 68 participants were enrolled and 35 were randomized.

Epilepsy clinic patients initially meeting trial eligibility on the basis of chart review completed a validated instrument that assesses the likelihood of having obstructive sleep apnea, and underwent a sleep and epilepsy evaluation by the site investigator. 68 patients consented, 33 not randomized due to not meeting criteria or declined.

Participant milestones

Participant milestones
Measure	Placebo Continuous Positive Airway Pressure With placebo continuous positive airway pressure, the subject feels like he/she is receiving the real treatment because of the presence of a blower and mask. However, there is a large leak that prevents the subject from receiving adequate pressurized air to keep the airway open.	Continuous Positive Airway Pressure Continuous positive airway pressure is a standard treatment for obstructive sleep apnea that uses pressurized air delivered through a mask to keep the airway open and prevent obstruction during sleep.
Overall Study STARTED	13	22
Overall Study COMPLETED	13	19
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Continuous Positive Airway Pressure With placebo continuous positive airway pressure, the subject feels like he/she is receiving the real treatment because of the presence of a blower and mask. However, there is a large leak that prevents the subject from receiving adequate pressurized air to keep the airway open.	Continuous Positive Airway Pressure Continuous positive airway pressure is a standard treatment for obstructive sleep apnea that uses pressurized air delivered through a mask to keep the airway open and prevent obstruction during sleep.
Overall Study Withdrawal by Subject	0	3

Baseline Characteristics

Effects of Treating Obstructive Sleep Apnea in Epilepsy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Continuous Positive Airway Pressure n=13 Participants With placebo continuous positive airway pressure, the subject feels like he/she is receiving the real treatment because of the presence of a blower and mask. However, there is a large leak that prevents the subject from receiving adequate pressurized air to keep the airway open.	Continuous Positive Airway Pressure n=22 Participants Continuous positive airway pressure is a standard treatment for obstructive sleep apnea that uses pressurized air delivered through a mask to keep the airway open and prevent obstruction during sleep.	Total n=35 Participants Total of all reporting groups
Age, Continuous	40.2 years STANDARD_DEVIATION 14.3 • n=5 Participants	42.7 years STANDARD_DEVIATION 12.3 • n=7 Participants	41.8 years STANDARD_DEVIATION 12.9 • n=5 Participants
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	13 Participants n=5 Participants	22 Participants n=7 Participants	35 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	14 Participants n=7 Participants	20 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	22 participants n=7 Participants	35 participants n=5 Participants

PRIMARY outcome

Timeframe: 10 weeks

This measure quantifies how well patients use their CPAP. The standard unit of measurement is proportion of nights that the CPAP is used by a participant (total nights used/total nights the device could have been used), averaged across all participants . Data were downloaded by a card placed in the CPAP machine reflecting use over the entire 10 weeks.

Outcome measures

Outcome measures
Measure	Placebo Continuous Positive Airway Pressure n=13 Participants With placebo continuous positive airway pressure, the subject feels like he/she is receiving the real treatment because of the presence of a blower and mask. However, there is a large leak that prevents the subject from receiving adequate pressurized air to keep the airway open.	Continuous Positive Airway Pressure n=22 Participants Continuous positive airway pressure is a standard treatment for obstructive sleep apnea that uses pressurized air delivered through a mask to keep the airway open and prevent obstruction during sleep.
CPAP Adherence/Tolerance as Measured by Proportion of Nights Used	0.74 proportion of nights used (total nights Standard Deviation 0.24	0.66 proportion of nights used (total nights Standard Deviation 0.3

SECONDARY outcome

Timeframe: 10 weeks

Patients all received a CPAP machine which either delivered CPAP or provided the patient with placebo CPAP, which had the same sensation as receiving CPAP

Outcome measures

Outcome measures
Measure	Placebo Continuous Positive Airway Pressure n=22 Participants With placebo continuous positive airway pressure, the subject feels like he/she is receiving the real treatment because of the presence of a blower and mask. However, there is a large leak that prevents the subject from receiving adequate pressurized air to keep the airway open.	Continuous Positive Airway Pressure n=13 Participants Continuous positive airway pressure is a standard treatment for obstructive sleep apnea that uses pressurized air delivered through a mask to keep the airway open and prevent obstruction during sleep.
Number of Patients That Were Able to be Blinded to CPAP or Placebo CPAP	22 participants	13 participants

SECONDARY outcome

Timeframe: prior to randomization

Population: These are participants that were enrolled and assessed to determine if one night of baseline sleep study was sufficient to detect sleep apnea. This occurred prior to randomization. Five of the assessed participants were not randomized.

The data presented below represent the number of participants who required only one night of baseline sleep study prior to randomization

Outcome measures

Outcome measures
Measure	Placebo Continuous Positive Airway Pressure n=40 Participants With placebo continuous positive airway pressure, the subject feels like he/she is receiving the real treatment because of the presence of a blower and mask. However, there is a large leak that prevents the subject from receiving adequate pressurized air to keep the airway open.	Continuous Positive Airway Pressure Continuous positive airway pressure is a standard treatment for obstructive sleep apnea that uses pressurized air delivered through a mask to keep the airway open and prevent obstruction during sleep.
Number of Patients Requiring Only One Night of Baseline Sleep Study to Detect Sleep Apnea	39 Participants	—

Adverse Events

Placebo Continuous Positive Airway Pressure

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Continuous Positive Airway Pressure

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo Continuous Positive Airway Pressure n=13 participants at risk With placebo continuous positive airway pressure, the subject feels like he/she is receiving the real treatment because of the presence of a blower and mask. However, there is a large leak that prevents the subject from receiving adequate pressurized air to keep the airway open.	Continuous Positive Airway Pressure n=22 participants at risk Continuous positive airway pressure is a standard treatment for obstructive sleep apnea that uses pressurized air delivered through a mask to keep the airway open and prevent obstruction during sleep.
Cardiac disorders tachycardia or chest tightness	7.7% 1/13 • Number of events 1	4.5% 1/22 • Number of events 1
Skin and subcutaneous tissue disorders skin irritation	0.00% 0/13	9.1% 2/22 • Number of events 2
Ear and labyrinth disorders nasal congestion	0.00% 0/13	4.5% 1/22 • Number of events 1
Gastrointestinal disorders GI discomfort	0.00% 0/13	4.5% 1/22 • Number of events 1
Psychiatric disorders anxiety	7.7% 1/13 • Number of events 1	0.00% 0/22

Additional Information

Beth Malow/Principal Investigator

Vanderbilt University

Phone: 615-322-0283

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place