Trial Outcomes & Findings for Evaluating the Relationship Between Sleep-Disordered Breathing and Daytime Alertness (NCT NCT00393913)
NCT ID: NCT00393913
Last Updated: 2016-08-05
Results Overview
Measured using the Epworth sleepiness scale (ESS). The Epworth sleepiness scale is used in the assessment of daytime sleepiness and measures the general level of sleepiness.The ESS presents the subject with eight situations and asks how likely they are to fall asleep (0= never, 1 =slight chance of dozing, 2= moderate chance of dozing and 3 =high chance of dozing) in these situations. The sum of the 8 answers is used as the score and ranges from 0 (not sleepy) to 24 (extremely sleepy), and a score of greater than 10 is an indication that a person may be excessively sleepy.
COMPLETED
144 participants
Baseline, CPAP( 4 -6 weeks), Off CPAP ( 2 nights)
2016-08-05
Participant Flow
Normal volunteers and patients with symptoms of sleep apnea evaluated at the NYU sleep disorders center.
Subjects with sleep disorders other than sleep apnea were not included for initial assessment of the effect of sleep apnea severity to daytime function.
Participant milestones
| Measure |
CPAP
All participants with sleep apnea will use a CPAP machine for treatment of sleep apnea.
|
|---|---|
|
Initial Assessment
STARTED
|
144
|
|
Initial Assessment
COMPLETED
|
107
|
|
Initial Assessment
NOT COMPLETED
|
37
|
|
CPAP
STARTED
|
100
|
|
CPAP
COMPLETED
|
93
|
|
CPAP
NOT COMPLETED
|
7
|
|
CPAP Withdrawal
STARTED
|
42
|
|
CPAP Withdrawal
CPAP Compliance
|
42
|
|
CPAP Withdrawal
COMPLETED
|
42
|
|
CPAP Withdrawal
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
CPAP
All participants with sleep apnea will use a CPAP machine for treatment of sleep apnea.
|
|---|---|
|
Initial Assessment
diagnosed with other sleep disorder
|
21
|
|
Initial Assessment
Withdrawal by Subject
|
16
|
|
CPAP
Withdrawal by Subject
|
3
|
|
CPAP
Physician Decision
|
1
|
|
CPAP
TEchnical problem with CPAP
|
3
|
Baseline Characteristics
Evaluating the Relationship Between Sleep-Disordered Breathing and Daytime Alertness
Baseline characteristics by cohort
| Measure |
Sleep Apnea Assessment
n=107 Participants
All participants were assigned to a single Arm (and received the intervention based on whether they had sleep apnea). Participants with sleep apnea used the CPAP machine for 4 to 6 weeks every night and then returned to the sleep laboratory for assessment of daytime function. Those without sleep apnea will have the initial assessment but then will not receive the intervention.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
103 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
45 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
107 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, CPAP( 4 -6 weeks), Off CPAP ( 2 nights)Measured using the Epworth sleepiness scale (ESS). The Epworth sleepiness scale is used in the assessment of daytime sleepiness and measures the general level of sleepiness.The ESS presents the subject with eight situations and asks how likely they are to fall asleep (0= never, 1 =slight chance of dozing, 2= moderate chance of dozing and 3 =high chance of dozing) in these situations. The sum of the 8 answers is used as the score and ranges from 0 (not sleepy) to 24 (extremely sleepy), and a score of greater than 10 is an indication that a person may be excessively sleepy.
Outcome measures
| Measure |
Sleep Apnea
n=107 Participants
All participants with obstructive sleep apnea (and no other sleep disorder) and subjects without sleep apnea.
|
|---|---|
|
Subjective Sleepiness
Baseline ESS
|
11.8 units on a scale
Standard Deviation 5.6
|
|
Subjective Sleepiness
CPAP ESS
|
10.2 units on a scale
Standard Deviation 5.0
|
|
Subjective Sleepiness
CPAP withdrawal ESS
|
9.9 units on a scale
Standard Deviation 4.6
|
PRIMARY outcome
Timeframe: Measured at baseline, on CPAP (4-6 weeks), CPAP withdrawal (2 nights)Multiple Sleep Latency Test (MSLT) measures the latency to sleep onset in minutes. The shorter the latency to sleep the more sleepy the subject.
Outcome measures
| Measure |
Sleep Apnea
n=107 Participants
All participants with obstructive sleep apnea (and no other sleep disorder) and subjects without sleep apnea.
|
|---|---|
|
Objective Sleepiness
Sleep Latency-Baseline
|
6.4 minutes
Standard Deviation 3.7
|
|
Objective Sleepiness
Sleep Latency-CPAP
|
5.9 minutes
Standard Deviation 3.1
|
|
Objective Sleepiness
Sleep Latency-CPAP withdrawal
|
7.8 minutes
Standard Deviation 4.1
|
PRIMARY outcome
Timeframe: Baseline, CPAP (4-6 weeks), CPAP withdrawal (2 nights)Population: Per protocol
Vigilance is measured using the psychomotor vigilance task which is a portable reaction time test that is contained in a small, programmable, portable electronic box that requires only a single switch to start. The task consists of responding to a small bright red light stimulus by pressing a response button as soon as the stimulus appears. This stops the stimulus counter and displays the reaction time (RT) in milliseconds for a 2-second period and the task duration is 20 minutes. The subject is instructed to press the button as soon as each stimulus appears in order to keep the reaction time as low as possible. The PVT yields highly informative metrics on the capacity for sustained attention including the frequency of lapses (reaction time \> 500 milliseconds). The higher the number of lapses the greater the impairment. Well rested (non-sleepy) subjects have almost no lapses(\<2) during the 20min test.
Outcome measures
| Measure |
Sleep Apnea
n=107 Participants
All participants with obstructive sleep apnea (and no other sleep disorder) and subjects without sleep apnea.
|
|---|---|
|
Vigilance
Baseline
|
5.9 Lapses
Standard Deviation 4.1
|
|
Vigilance
CPAP
|
4.1 Lapses
Standard Deviation 2.6
|
|
Vigilance
CPAP withdrawal
|
6.5 Lapses
Standard Deviation 4.5
|
Adverse Events
Continuous Positive Pressure Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place