Trial Outcomes & Findings for A High Density EEG Comparison of Sleep Patterns in Insomnia (NCT NCT01960452)
NCT ID: NCT01960452
Last Updated: 2025-01-09
Results Overview
The difference in spontaneous NREM sleep (stage N2 or N3) EEG power between subjects with insomnia and good sleeping controls measured with 256 channel high-density EEG equipment. Reported here is the median spectral power estimated using Welch's method (MATLAB function pwelch) across all 6 second epochs staged by a registered sleep technician as NREM sleep stage N2 or N3 sleep. The median spectral estimate across all NREM epochs was used to estimate spectral power for each subject as this value is robust to outliers from individual sleep epochs. The Welch's method done in this way estimates frequency content in .33 Hz bins which are then averaged across the spindle frequency band range (12 - 16Hz) from the approximate CP1 electrode (channel 89). The value reported below is the MEAN of the median spectral estimate. Higher values represent more spindle band activity. This frequency range and location showed the most consistent difference between groups across outcome measures.
COMPLETED
45 participants
Individual night of sleep recorded on average within 4 weeks of enrollment (Night 1, Baseline EEG)
2025-01-09
Participant Flow
Participant milestones
| Measure |
Primary Insomnia
Participants classified as having insomnia through clinical interview, questionnaires, actigraphy, and sleep log data as well as meeting other eligibility criteria.
|
Healthy Sleeping Controls
Participants classified as having healthy sleep through clinical interview, questionnaires, actigraphy, and sleep log data as well as meeting other eligibility criteria.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
22
|
|
Overall Study
COMPLETED
|
17
|
17
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
| Measure |
Primary Insomnia
Participants classified as having insomnia through clinical interview, questionnaires, actigraphy, and sleep log data as well as meeting other eligibility criteria.
|
Healthy Sleeping Controls
Participants classified as having healthy sleep through clinical interview, questionnaires, actigraphy, and sleep log data as well as meeting other eligibility criteria.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Sleep apnea in Night 1
|
1
|
0
|
|
Overall Study
Poor Sleep in Night 1
|
0
|
2
|
|
Overall Study
No Sex/Age Match Night 1
|
1
|
0
|
|
Overall Study
No Sex/Age Match Night 2
|
0
|
2
|
|
Overall Study
Technical Difficulties Night 2
|
2
|
0
|
Baseline Characteristics
A High Density EEG Comparison of Sleep Patterns in Insomnia
Baseline characteristics by cohort
| Measure |
Primary Insomnia
n=19 Participants
Participants classified as having insomnia through clinical interview, questionnaires, actigraphy, and sleep log data as well as meeting other eligibility criteria.
|
Healthy Sleeping Controls
n=19 Participants
Participants classified as having healthy sleep through clinical interview, questionnaires, actigraphy, and sleep log data as well as meeting other eligibility criteria.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.8 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
31.1 years
STANDARD_DEVIATION 8.1 • n=7 Participants
|
30.9 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
19 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Insomnia Severity Index
|
14.8 units on a scale
STANDARD_DEVIATION 3.1 • n=5 Participants
|
1.2 units on a scale
STANDARD_DEVIATION 1.5 • n=7 Participants
|
8.0 units on a scale
STANDARD_DEVIATION 7.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: Individual night of sleep recorded on average within 4 weeks of enrollment (Night 1, Baseline EEG)The difference in spontaneous NREM sleep (stage N2 or N3) EEG power between subjects with insomnia and good sleeping controls measured with 256 channel high-density EEG equipment. Reported here is the median spectral power estimated using Welch's method (MATLAB function pwelch) across all 6 second epochs staged by a registered sleep technician as NREM sleep stage N2 or N3 sleep. The median spectral estimate across all NREM epochs was used to estimate spectral power for each subject as this value is robust to outliers from individual sleep epochs. The Welch's method done in this way estimates frequency content in .33 Hz bins which are then averaged across the spindle frequency band range (12 - 16Hz) from the approximate CP1 electrode (channel 89). The value reported below is the MEAN of the median spectral estimate. Higher values represent more spindle band activity. This frequency range and location showed the most consistent difference between groups across outcome measures.
Outcome measures
| Measure |
Primary Insomnia
n=19 Participants
An initial baseline 256 channel high-density EEG polysomnographic recording was acquired using an Electrical Geodesics NetAmps 300 System (256 EEG channels) integrated with clinical polysomnography (PSG) from the Alice 5 Sleepware system (hdPSG). This baseline recording included electrooculogram (EOG), chin and leg electromyography (EMG), electrocardiogram (EKG), blood oxygen level (SpO2), respiration belts, a snore microphone and a position sensor and was used to rule out clinical sleep disorders other than insomnia. Lights off typically occurred within 30 minutes of subjects normal sleep time and subjects were allowed to sleep ad libitum. Sleep staging and arousal detection was performed by a sleep technician according to American Academy of Sleep Medicine standard criteria. Data was included for all subjects who completed the sleep recording and had a suitable sex and age matched control.
|
Healthy Sleeping Controls
n=19 Participants
An initial baseline 256 channel high-density EEG polysomnographic recording was acquired using an Electrical Geodesics NetAmps 300 System (256 EEG channels) integrated with clinical polysomnography (PSG) from the Alice 5 Sleepware system (hdPSG). This baseline recording included electrooculogram (EOG), chin and leg electromyography (EMG), electrocardiogram (EKG), blood oxygen level (SpO2), respiration belts, a snore microphone and a position sensor and was used to rule out clinical sleep disorders. Lights off typically occurred within 30 minutes of subjects normal sleep time and subjects were allowed to sleep ad libitum. Sleep staging and arousal detection was performed by a sleep technician according to American Academy of Sleep Medicine standard criteria. Data was included for all subjects who completed the sleep recording and had a suitable sex and age matched insomnia participant.
|
|---|---|---|
|
EEG Power During Sleep
|
1.40 μV^2/Hz
Interval 0.68 to 3.17
|
1.17 μV^2/Hz
Interval 0.38 to 2.46
|
PRIMARY outcome
Timeframe: 30 seconds of NREM sleep prior to serial awakening (Night 2, Serial Awakening EEG)The difference in 30 seconds of spontaneous NREM (stage N2 or N3) sleep EEG power prior to serial awakening between subjects with insomnia and good sleeping controls measured with 256 channel high-density EEG equipment. Reported here is the median spectral power estimated using Welch's method (2 second epochs) of the 30 seconds of NREM sleep stage N2 or N3 sleep immediately prior to the 40dB tone played to initiate a serial awakening sequence. The median spectral estimate across epochs was used to estimate spectral power for each subject as this value is robust to outliers from individual epochs. The Welch's method done in this way estimates frequency content in .5 Hz bins which are then averaged across the spindle frequency band range (12 - 16Hz) from the approximate CP1 electrode (channel 89). Each subject had between 4 - 10 serial awakenings from NREM sleep. The value reported below is the MEAN of the median spectral estimate. Higher values represent more spindle band activity.
Outcome measures
| Measure |
Primary Insomnia
n=17 Participants
An initial baseline 256 channel high-density EEG polysomnographic recording was acquired using an Electrical Geodesics NetAmps 300 System (256 EEG channels) integrated with clinical polysomnography (PSG) from the Alice 5 Sleepware system (hdPSG). This baseline recording included electrooculogram (EOG), chin and leg electromyography (EMG), electrocardiogram (EKG), blood oxygen level (SpO2), respiration belts, a snore microphone and a position sensor and was used to rule out clinical sleep disorders other than insomnia. Lights off typically occurred within 30 minutes of subjects normal sleep time and subjects were allowed to sleep ad libitum. Sleep staging and arousal detection was performed by a sleep technician according to American Academy of Sleep Medicine standard criteria. Data was included for all subjects who completed the sleep recording and had a suitable sex and age matched control.
|
Healthy Sleeping Controls
n=17 Participants
An initial baseline 256 channel high-density EEG polysomnographic recording was acquired using an Electrical Geodesics NetAmps 300 System (256 EEG channels) integrated with clinical polysomnography (PSG) from the Alice 5 Sleepware system (hdPSG). This baseline recording included electrooculogram (EOG), chin and leg electromyography (EMG), electrocardiogram (EKG), blood oxygen level (SpO2), respiration belts, a snore microphone and a position sensor and was used to rule out clinical sleep disorders. Lights off typically occurred within 30 minutes of subjects normal sleep time and subjects were allowed to sleep ad libitum. Sleep staging and arousal detection was performed by a sleep technician according to American Academy of Sleep Medicine standard criteria. Data was included for all subjects who completed the sleep recording and had a suitable sex and age matched insomnia participant.
|
|---|---|---|
|
EEG Power Examined Before Arousal From Sleep on Serial Awakening Night
|
1.20 μV^2/Hz
Interval 0.59 to 2.09
|
0.93 μV^2/Hz
Interval 0.22 to 1.7
|
PRIMARY outcome
Timeframe: 30 seconds of falling asleep EEG immediately after the first non-waking epoch following a serial awakening and proceeding 5 minutes of stable sleep (Night 2, Serial Awakening EEG)The difference in 30 seconds of spontaneous falling asleep EEG power between subjects with insomnia and good sleeping controls measured with 256 channel high-density EEG equipment. Reported here is the median spectral power estimated using Welch's method with 2 second epochs from the 30 seconds of sleep immediately following a serial awakening (starting after the last waking epoch) that resulted in the subject reaching 5 minutes of stable sleep averaged across the spindle frequency band range 12 - 16Hz from the approximate CP1 electrode (channel 89) and across all serial awakening falling asleep periods for each subject. Each subject had between 4 - 8 falling asleep periods that resulted in 5 minutes of stable sleep within 30 minutes of the serial awakening attempt. The value reported below is the MEAN of the median spectral estimate. Higher values represent more spindle band activity.
Outcome measures
| Measure |
Primary Insomnia
n=17 Participants
An initial baseline 256 channel high-density EEG polysomnographic recording was acquired using an Electrical Geodesics NetAmps 300 System (256 EEG channels) integrated with clinical polysomnography (PSG) from the Alice 5 Sleepware system (hdPSG). This baseline recording included electrooculogram (EOG), chin and leg electromyography (EMG), electrocardiogram (EKG), blood oxygen level (SpO2), respiration belts, a snore microphone and a position sensor and was used to rule out clinical sleep disorders other than insomnia. Lights off typically occurred within 30 minutes of subjects normal sleep time and subjects were allowed to sleep ad libitum. Sleep staging and arousal detection was performed by a sleep technician according to American Academy of Sleep Medicine standard criteria. Data was included for all subjects who completed the sleep recording and had a suitable sex and age matched control.
|
Healthy Sleeping Controls
n=17 Participants
An initial baseline 256 channel high-density EEG polysomnographic recording was acquired using an Electrical Geodesics NetAmps 300 System (256 EEG channels) integrated with clinical polysomnography (PSG) from the Alice 5 Sleepware system (hdPSG). This baseline recording included electrooculogram (EOG), chin and leg electromyography (EMG), electrocardiogram (EKG), blood oxygen level (SpO2), respiration belts, a snore microphone and a position sensor and was used to rule out clinical sleep disorders. Lights off typically occurred within 30 minutes of subjects normal sleep time and subjects were allowed to sleep ad libitum. Sleep staging and arousal detection was performed by a sleep technician according to American Academy of Sleep Medicine standard criteria. Data was included for all subjects who completed the sleep recording and had a suitable sex and age matched insomnia participant.
|
|---|---|---|
|
EEG Power Examined as Subjects Fall Asleep on Serial Awakening Night
|
0.57 μV^2/Hz
Interval 0.42 to 2.09
|
0.50 μV^2/Hz
Interval 0.39 to 1.0
|
Adverse Events
Primary Insomnia
Healthy Sleeping Controls
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