It is hypothesized that treating insomnia in migraineurs, many of whom also have tension headaches, prolongs total sleep time to the extent that it decreases overall headache frequency. Chronic headache sufferers also feel more tired during the day, undoubtedly affecting daytime functioning, which is hypothesized to improve as well with prolonged total sleep time.
The objective of the study is to determine the effect of prolonging total sleep time in migraineurs with insomnia on overall headache frequency, daytime alertness, fatigue, and functioning. The prolongation of total sleep time is accomplished by bedtime administration of 3 mg eszopiclone (Lunesta™), compared with placebo through a parallel-group design.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
113
3 mg tablet every night at bedtime
1 tablet every night at bedtime
Total Sleep Time
Participants were asked to record an estimated total time asleep on a daily basis. Nightly estimates were averaged over a 2 week period for baseline and 6 week period so that the total sleep time represents the average total time asleep each night.
Time frame: Baseline, 6 weeks
Nighttime Awakenings
Participants were asked to keep a daily record. 6 week data were averaged over the 6 week period
Time frame: Baseline, 6 weeks
Nighttime Awakenings
Participants were asked to keep a daily record. The average among weeks 1 and 2, weeks 3 and 4, and weeks 5 and 6 were taken, resulting in 3 averages, where the lowest average is reported as the minimum value of the full range, the middle average is reported as the median, and the highest average is reported as the maximum value of the full range
Time frame: Measured every two weeks (1&2, 3&4, 5&6)
Quality of Sleep
Participants were asked to keep a daily record. 6 week data were averaged over the 6 week period * Overall sleep quality was measured on a scale of 1=poor to 10=excellent. * Daytime alertness was measured on a scale of 1=not alert to 10=extremely alert. * Daytime fatigue was measured on a scale of 1=not tired to 10=extremely tired. * Daytime functioning was measured on a scale of 1=poor to 10=excellent.
Time frame: Baseline, 6 weeks
Daytime Fatigue
Participants were asked to keep a daily record. * Daytime fatigue was measured on a scale of 1=not tired to 10=extremely tired. The average among weeks 1 and 2, weeks 3 and 4, and weeks 5 and 6 were taken, resulting in 3 averages, where the lowest average is reported as the minimum value of the full range, the middle average is reported as the median, and the highest average is reported as the maximum value of the full range
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Time frame: Measured every two weeks (1&2, 3&4, 5&6)
Headache Frequency
Number of days per week in which a participant had a headache. Participants were asked to keep a daily record. 6 week data were averaged over the 6 week period
Time frame: Baseline, 6 weeks
Headache Duration
Participants were asked to keep a daily record. 6 week data were averaged over the 6 week period
Time frame: Baseline, 6 weeks
Headache Intensity
Participants were asked to keep a daily record. 6 week data were averaged over the 6 week period * Headache intensity was measured on a scale of 1=not intense to 10=worst headache possible
Time frame: Baseline, 6 weeks