Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Change in sustained attention assessed with the Psychomotor Vigilance Task from morning to afternoon and then evening from baseline days to the first and second cycles of sleep restriction and recovery |
Number of attention lapses (>500ms) |
5 times daily for 16 days |
|
Primary |
Change in mean reaction time assessed with the Psychomotor Vigilance Task from morning to afternoon and then evening from baseline days to the first and second cycles of sleep restriction and recovery |
Mean reaction time |
5 times daily for 16 days |
|
Primary |
Change in median reaction time assessed with the Psychomotor Vigilance Task from morning to afternoon and then evening from baseline days to the first and second cycles of sleep restriction and recovery |
Median reaction time |
5 times daily for 16 days |
|
Primary |
Change in standard deviation in reaction time of sleep restriction and recovery |
Standard deviation in reaction time |
5 times daily for 16 days |
|
Primary |
Change in number of commission errors / false starts assessed with the Psychomotor Vigilance Task from morning to afternoon and then evening from baseline days to the first and second cycles of sleep restriction and recovery |
Number of commission errors / false starts |
5 times daily for 16 days |
|
Primary |
Change in number of correct matches assessed with the 1-back task from morning to afternoon and then evening from baseline days to the first and second cycles of sleep manipulation and recovery |
Number of correct matches in the 1-back task |
5 times daily for 16 days |
|
Primary |
Change in number of correct mismatches assessed with the1-back task from morning to afternoon and then evening from baseline days to the first and second cycles of sleep manipulation and recovery |
Number of correct mismatches in the 1-back task |
5 times daily for 16 days |
|
Primary |
Change in number of incorrect matches assessed with the1-back task from morning to afternoon and then evening from baseline days to the first and second cycles of sleep manipulation and recovery |
Number of incorrect matches in the 1-back task |
5 times daily for 16 days |
|
Primary |
Change in incorrect mismatches assessed with the1-back task from morning to afternoon and then evening from baseline days to the first and second cycles of sleep manipulation and recovery |
Number of incorrect mismatches in the 1-back task |
5 times daily for 16 days |
|
Primary |
Change in discriminability measure (A') assessed with the1-back task from morning to afternoon and then evening from baseline days to the first and second cycles of sleep manipulation and recovery |
Discriminability measure (A') |
5 times daily for 16 days |
|
Primary |
Change in bias measure (B"D) assessed with the1-back task from morning to afternoon and then evening from baseline days to the first and second cycles of sleep manipulation and recovery |
Bias measure (B"D) |
5 times daily for 16 days |
|
Primary |
Change in number of correct matches assessed with the 3-back task from morning to afternoon and then evening from baseline days to the first and second cycles of sleep manipulation and recovery |
Number of correct matches in the 3-back task |
5 times daily for 16 days |
|
Primary |
Change in number of correct mismatches assessed with the 3-back task from morning to afternoon and then evening from baseline days to the first and second cycles of sleep manipulation and recovery |
Number of correct mismatches in the 3-back task |
5 times daily for 16 days |
|
Primary |
Change in number of incorrect matches assessed with the 3-back task from morning to afternoon and then evening from baseline days to the first and second cycles of sleep manipulation and recovery |
Number of incorrect matches in the 3-back task |
5 times daily for 16 days |
|
Primary |
Change in number of incorrect mismatches assessed with the 3-back task from morning to afternoon and then evening from baseline days to the first and second cycles of sleep manipulation and recovery |
Number of incorrect mismatches in the 3-back task |
5 times daily for 16 days |
|
Primary |
Change in discriminability measure (A') assessed with the 3-back task from morning to afternoon and then evening from baseline days to the first and second cycles of sleep manipulation and recovery |
Discriminability measure (A') |
5 times daily for 16 days |
|
Primary |
Change in bias measure (B"D) assessed with the 3-back task from morning to afternoon and then evening from baseline days to the first and second cycles of sleep manipulation and recovery |
Bias measure (B"D) |
5 times daily for 16 days |
|
Primary |
Change in the level of subjective sleepiness assessed with the Karolinska Sleepiness Scale from morning to afternoon then evening from baseline days to the first and second cycle of sleep manipulation and recovery |
Score on the Karolinska Sleepiness Scale (1-9 points) |
5 times daily for 16 days |
|
Primary |
Change in positive mood assessed with the Positive and Negative Affect Scale (PANAS) from morning to afternoon and then evening from baseline days to the first and second cycles of sleep manipulation and recovery |
Total score on the positive subscale of the PANAS |
5 times daily for 16 days |
|
Primary |
Change in negative mood assessed with the Positive and Negative Affect Scale (PANAS) from morning to afternoon and then evening from baseline days to the first and second cycles of sleep manipulation and recovery |
Total score on the negative subscale of the PANAS |
5 times daily for 16 days |
|
Primary |
Change in the level of depressive symptomatology from the mornings of the second baseline day to the last day of the first sleep manipulation cycle and the last day of the second sleep manipulation cycle. |
Score on the Mood and Anxiety Symptom Questionnaire (Scale 1-5) |
3 separate days (Day 3, 8 and 15) |
|
Primary |
Change in the level of anxiety symptomatology from the mornings of the second baseline day to the last day of the first sleep manipulation cycle and the last day of the second sleep manipulation cycle. |
Score on the Mood and Anxiety Symptom Questionnaire (Scale 1-5) |
3 separate days (Day 3, 8 and 15) |
|
Primary |
Change in the level of satisfaction with life from morning to afternoon and then evening from baseline days to the first and second cycles of sleep manipulation and recovery |
Score on the Satisfaction with Life Scale (1-7 scale) |
5 times daily (09:00, 12:00, 15:00, 18:00, 21:00) for 16 days |
|
Primary |
Change in speed of processing assessed with the Mental Arithmetic Test (MAT) from morning to afternoon and then evening from baseline days to the first and second cycles of sleep manipulation and recovery |
Number of correct response in the task |
5 times daily (09:00, 12:00, 15:00, 18:00, 21:00) for 16 days |
|
Primary |
Change in speed of processing assessed with the Symbol Digit Modalities Test from morning to afternoon and then evening from baseline days to the first and second cycles of sleep manipulation and recovery |
Number of correct responses in the task |
5 times daily (09:00, 12:00, 15:00, 18:00, 21:00) for 16 days |
|
Primary |
Changes in the blood glucose levels from morning of the second baseline day to the last day of the first sleep manipulation cycle and the last day of the second sleep manipulation cycle. |
Area under the curve for plasma glucose |
3 days (Day 3, 8 and 15) 6mL blood sample collection at 15, 30, 60, and 120 minutes |
|
Primary |
Changes in the insulin levels from morning of the second baseline day to the last day of the first sleep manipulation cycle and the last day of the second sleep manipulation cycle. |
Area under the curve for insulin |
3 days (Day 3, 8 and 15) 6mL blood sample collection at 15, 30, 60, and 120 minutes |
|
Primary |
Changes in interstitial fluid glucose levels from morning to afternoon then evening from baseline days to the first and second cycles of sleep manipulation and recovery. |
Area under the curve for interstitial fluid glucose |
All 16-days with 8-hour interval readings |
|
Primary |
Changes in the task related brain functional connectivity from the second baseline day to the last day of the first sleep manipulation cycle and the last day of the second sleep manipulation cycle. |
Brain functional connectivity in fMRI analysis |
3 days (Day 3, 8, 15) |
|
Primary |
Changes in the resting-state brain functional connectivity from the second baseline day to the last day of the first sleep manipulation cycle and the last day of the second sleep manipulation cycle. |
Brain functional connectivity in fMRI analysis |
3 days (Day 3, 8, 15) |
|
Primary |
Effect of variable sleep on picture encoding response time |
Mean response time |
Single session (Day 8) |
|
Primary |
Effect of variable sleep on picture encoding response accuracy |
Response accuracy |
Single session (Day 8) |
|
Primary |
Effect of variable sleep on picture recognition response time |
Mean response time |
Single session (Day 10) |
|
Primary |
Effect of variable sleep on picture recognition hit rate |
Hit rate |
Single session (Day 10) |
|
Primary |
Effect of variable sleep on picture recognition false alarm rate |
False alarm rate |
Single session (Day 10) |
|
Primary |
Effect of variable sleep on picture recognition discriminability measure (A') |
Discriminability measure (A') |
Single session (Day 10) |
|
Secondary |
Change in total sleep duration at night assessed with polysomnography from baseline nights to the first and second cycles of sleep manipulation and recovery |
Total duration of nocturnal sleep will be determined to establish baseline sleep characteristics (first and second night) and changes in the first sleep manipulation period (third, fourth, fifth, sixth and seventh sleep) the first recovery period (eight and ninth night), the second sleep manipulation period (tenth, eleventh, twelfth, thirteenth, fourteenth), and the second recovery period (15th night) |
Nocturnal sleep on nights 1 & 2 (baseline), 3, 4, 5, 6 & 7 (first sleep manipulation period), 8 & 9 (first recovery period), 10,11,12, 13, 14 (second sleep manipulation period), & 15 (second recovery period) |
|
Secondary |
Change in wake after sleep onset duration at night assessed with polysomnography from baseline nights to the first and second cycles of sleep manipulation and recovery |
Total duration of wake after sleep onset will be determined to establish baseline sleep characteristics (first and second night) and changes in the first sleep manipulation period (third, fourth, fifth, sixth and seventh sleep) the first recovery period (eight and ninth night), the second sleep manipulation period (tenth, eleventh, twelfth, thirteenth, fourteenth), and the second recovery period (15th night) |
Nocturnal sleep on nights 1 & 2 (baseline), 3, 4, 5, 6 & 7 (first sleep manipulation period), 8 & 9 (first recovery period), 10,11,12, 13, 14 (second sleep manipulation period), & 15 (second recovery period) |
|
Secondary |
Change sleep efficiency at night assessed with polysomnography from baseline nights to the first and second cycles of sleep manipulation and recovery |
Total sleep efficiency will be determined to establish baseline sleep characteristics (first and second night) and changes in the first sleep manipulation period (third, fourth, fifth, sixth and seventh sleep) the first recovery period (eight and ninth night), the second sleep manipulation period (tenth, eleventh, twelfth, thirteenth, fourteenth), and the second recovery period (15th night) |
Nocturnal sleep on nights 1 & 2 (baseline), 3, 4, 5, 6 & 7 (first sleep manipulation period), 8 & 9 (first recovery period), 10,11,12, 13, 14 (second sleep manipulation period), & 15 (second recovery period) |
|
Secondary |
Change slow wave activity/ slow wave energy at night assessed with polysomnography from baseline nights to the first and second cycles of sleep manipulation and recovery |
Total slow wave activity/ slow wave energy will be determined to establish baseline sleep characteristics (first and second night) and changes in the first sleep manipulation period (third, fourth, fifth, sixth and seventh sleep) the first recovery period (eight and ninth night), the second sleep manipulation period (tenth, eleventh, twelfth, thirteenth, fourteenth), and the second recovery period (15th night) |
Nocturnal sleep on nights 1 & 2 (baseline), 3, 4, 5, 6 & 7 (first sleep manipulation period), 8 & 9 (first recovery period), 10,11,12, 13, 14 (second sleep manipulation period), & 15 (second recovery period) |
|
Secondary |
Change spindle activity at night assessed with polysomnography from baseline nights to the first and second cycles of sleep manipulation and recovery |
Total spindle activity will be determined to establish baseline sleep characteristics (first and second night) and changes in the first sleep manipulation period (third, fourth, fifth, sixth and seventh sleep) the first recovery period (eight and ninth night), the second sleep manipulation period (tenth, eleventh, twelfth, thirteenth, fourteenth), and the second recovery period (15th night) |
Nocturnal sleep on nights 1 & 2 (baseline), 3, 4, 5, 6 & 7 (first sleep manipulation period), 8 & 9 (first recovery period), 10,11,12, 13, 14 (second sleep manipulation period), & 15 (second recovery period) |
|
Secondary |
Change in N1 sleep duration at night assessed with polysomnography from baseline nights to the first and second cycles of sleep manipulation and recovery |
Total duration of nocturnal N1 sleep duration will be determined to establish baseline sleep characteristics (first and second night) and changes in the first sleep manipulation period (third, fourth, fifth, sixth and seventh sleep) the first recovery period (eight and ninth night), the second sleep manipulation period (tenth, eleventh, twelfth, thirteenth, fourteenth), and the second recovery period (15th night) |
Nocturnal sleep on nights 1 & 2 (baseline), 3, 4, 5, 6 & 7 (first sleep manipulation period), 8 & 9 (first recovery period), 10,11,12, 13, 14 (second sleep manipulation period), & 15 (second recovery period) |
|
Secondary |
Change in N1 sleep percentage at night assessed with polysomnography from baseline nights to the first and second cycles of sleep manipulation and recovery |
Percentage of nocturnal N1 sleep duration will be determined to establish baseline sleep characteristics (first and second night) and changes in the first sleep manipulation period (third, fourth, fifth, sixth and seventh sleep) the first recovery period (eight and ninth night), the second sleep manipulation period (tenth, eleventh, twelfth, thirteenth, fourteenth), and the second recovery period (15th night) |
Nocturnal sleep on nights 1 & 2 (baseline), 3, 4, 5, 6 & 7 (first sleep manipulation period), 8 & 9 (first recovery period), 10,11,12, 13, 14 (second sleep manipulation period), & 15 (second recovery period) |
|
Secondary |
Change in N2 sleep duration at night assessed with polysomnography from baseline nights to the first and second cycles of sleep manipulation and recovery |
Duration of nocturnal N2 sleep will be determined to established baseline sleep characteristics (first and second night) and changes in the first sleep manipulation period (third, fourth, fifth, sixth and seventh sleep) the first recovery period (eight and ninth night), the second sleep manipulation period (tenth, eleventh, twelfth, thirteenth, fourteenth), and the second recovery period (15th night)(first and second nights) and changes in the first sleep manipulation (third, forth, fifth, sixth |
Nocturnal sleep on nights 1 & 2 (baseline), 3, 4, 5, 6 & 7 (first sleep manipulation period), 8 & 9 (first recovery period), 10,11,12, 13, 14 (second sleep manipulation period), & 15 (second recovery period) |
|
Secondary |
Change in N2 sleep percentage at night assessed with polysomnography from baseline nights to the first and second cycles of sleep manipulation and recovery |
Percentage of nocturnal N2 sleep will be determined to established baseline sleep characteristics (first and second night) and changes in the first sleep manipulation period (third, fourth, fifth, sixth and seventh sleep) the first recovery period (eight and ninth night), the second sleep manipulation period (tenth, eleventh, twelfth, thirteenth, fourteenth), and the second recovery period (15th night)(first and second nights) and changes in the first sleep manipulation (third, forth, fifth, sixth |
Nocturnal sleep on nights 1 & 2 (baseline), 3, 4, 5, 6 & 7 (first sleep manipulation period), 8 & 9 (first recovery period), 10,11,12, 13, 14 (second sleep manipulation period), & 15 (second recovery period) |
|
Secondary |
Change in N2 sleep latency at night assessed with polysomnography from baseline nights to the first and second cycles of sleep manipulation and recovery |
Duration of nocturnal N2 sleep latency will be determined to established baseline sleep characteristics (first and second night) and changes in the first sleep manipulation period (third, fourth, fifth, sixth and seventh sleep) the first recovery period (eight and ninth night), the second sleep manipulation period (tenth, eleventh, twelfth, thirteenth, fourteenth), and the second recovery period (15th night)(first and second nights) and changes in the first sleep manipulation (third, forth, fifth, sixth |
Nocturnal sleep on nights 1 & 2 (baseline), 3, 4, 5, 6 & 7 (first sleep manipulation period), 8 & 9 (first recovery period), 10,11,12, 13, 14 (second sleep manipulation period), & 15 (second recovery period) |
|
Secondary |
Change in N3 sleep duration at night assessed with polysomnography from baseline nights to the first and second cycles of sleep manipulation and recovery |
Total duration of nocturnal N3 sleep will be determined to establish baseline sleep characteristics (first and second night) and changes in the first sleep manipulation period (third, fourth, fifth, sixth, and seventh sleep) the first recovery period (eight and ninth night), the second sleep manipulation period (tenth, eleventh, twelfth, thirteenth, fourteenth), and the second recovery period (15th night) |
Nocturnal sleep on nights 1 & 2 (baseline), 3, 4, 5, 6 & 7 (first sleep manipulation period), 8 & 9 (first recovery period), 10,11,12, 13, 14 (second sleep manipulation period), & 15 (second recovery period) |
|
Secondary |
Change in N3 sleep percentage at night assessed with polysomnography from baseline nights to the first and second cycles of sleep manipulation and recovery |
Percentage of nocturnal N3 sleep will be determined to establish baseline sleep characteristics (first and second night) and changes in the first sleep manipulation period (third, fourth, fifth, sixth, and seventh sleep) the first recovery period (eight and ninth night), the second sleep manipulation period (tenth, eleventh, twelfth, thirteenth, fourteenth), and the second recovery period (15th night) |
Nocturnal sleep on nights 1 & 2 (baseline), 3, 4, 5, 6 & 7 (first sleep manipulation period), 8 & 9 (first recovery period), 10,11,12, 13, 14 (second sleep manipulation period), & 15 (second recovery period) |
|
Secondary |
Change in the Rapid Eye Movement (REM) sleep duration at night with polysomnography from baseline nights to the first and second cycles of sleep manipulation and recovery |
Duration of nocturnal sleep REM sleep will be determined to establish baseline sleep characteristics (first and second night) and changes in the first sleep manipulation period (third, fourth, fifth, sixth and seventh sleep) the first recovery period (eight and ninth night), the second sleep manipulation period (tenth, eleventh, twelfth, thirteenth, fourteenth), and the second recovery period (15th night) |
Nocturnal sleep on nights 1 & 2 (baseline), 3, 4, 5, 6 & 7 (first sleep manipulation period), 8 & 9 (first recovery period), 10,11,12, 13, 14 (second sleep manipulation period), & 15 (second recovery period) |
|
Secondary |
Change in the Rapid Eye Movement (REM) sleep percentage at night with polysomnography from baseline nights to the first and second cycles of sleep manipulation and recovery |
Percentage of nocturnal sleep REM sleep will be determined to establish baseline sleep characteristics (first and second night) and changes in the first sleep manipulation period (third, fourth, fifth, sixth and seventh sleep) the first recovery period (eight and ninth night), the second sleep manipulation period (tenth, eleventh, twelfth, thirteenth, fourteenth), and the second recovery period (15th night) |
Nocturnal sleep on nights 1 & 2 (baseline), 3, 4, 5, 6 & 7 (first sleep manipulation period), 8 & 9 (first recovery period), 10,11,12, 13, 14 (second sleep manipulation period), & 15 (second recovery period) |
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