Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00167375
Status:
COMPLETED
Last Update Posted:
2008-02-15
First Post:
2005-09-09
Brief Title:
Testing the Nocturnal Sleep Latency Profile in Primary Insomnia
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Testing the Nocturnal Sleep Latency Profile in Primary Insomnia
Status:
COMPLETED
Status Verified Date:
2008-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study tests a new kind of sleep study in which subjects are awakened 2 times after initially going to sleep The study focuses on the EEG signal process as a person goes to sleep The general hypothesis is that the signal properties are stable from night to night during baseline studies and are different between controls and patients with primary insomnia The primary insomnia patients then go on to have about 2 weeks of an insomnia intervention Then the new kind of study is repeated in the patients The controls only are examined in baseline studies
Detailed Description:
Patients are carefully screened to have DSM primary insomnia and do not have another disorder than may cause a sleep disturbance After a 2-week baseline period the subjects undergo a screening sleep study to rule out sleep apnea and periodic limb movement disorder Then they undergo the NSLP procedure In that procedure there pre-bedtime EEG recordings and questionnaire responses taken Then at a planned time the subjects go to bed and try to sleep while there EEG signals are recorded After the first and second sleep cycles they are awakened for one minute then asked to return to sleep In the morning additional recordings and questionnaire responses are obtained Two nights later they repeat a baseline NSLP procedure The controls then end their participation The Patients then receive an open treatment with eszopiclone and behavioral treatments so that their insomnia may improve After 2 weeks intervention the patients complete one NLSP night The goal of the study is to see if there can be data to support the idea that the sleep onset process might harbor a sign of primary insomnia that could be used for the development of a better medical model of primary insomnia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 27-CA-04 | None | None | None |