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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00705601 |
To begin to refine development of the RSQ (Restorative Sleep Questionnaire) measure in subjects with NRS (Nonrestorative Sleep) by generating item content pertaining to morning refreshment and uncovering problems in instrument administration in subjects with nonrestorative sleep
Condition | Intervention | Phase |
---|---|---|
Nonrestorative Sleep |
Procedure: PSG |
Phase II |
Study Type: | Interventional |
Study Design: | Screening, Non-Randomized, Open Label, Single Group Assignment |
Official Title: | Refinement Of Patient Reported Outcomes Instruments In Subjects With Insomnia Characterized By Nonrestorative Sleep |
Estimated Enrollment: | 65 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1 |
Procedure: PSG
PSG (polysomnography) for adaptation night, day 2 evening, and day 3 evening--used to identify suitable Nonrestorative Sleep candidates to participate in focus groups.
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Ages Eligible for Study: | 18 Years to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
United States, California | |
Pfizer Investigational Site | Not yet recruiting |
Tustin, California, United States, 92780 | |
Pfizer Investigational Site | Not yet recruiting |
Pasadena, California, United States, 91106 | |
Pfizer Investigational Site | Recruiting |
San Diego, California, United States, 92121 | |
Pfizer Investigational Site | Active, not recruiting |
Fountain Valley, California, United States, 92708 | |
United States, Florida | |
Pfizer Investigational Site | Active, not recruiting |
Pembroke Pines, Florida, United States, 33026 | |
Pfizer Investigational Site | Recruiting |
Miami, Florida, United States, 33143 | |
United States, Georgia | |
Pfizer Investigational Site | Recruiting |
Atlanta, Georgia, United States, 30342 | |
United States, Kansas | |
Pfizer Investigational Site | Recruiting |
Overland Park, Kansas, United States, 66212 | |
United States, Kentucky | |
Pfizer Investigational Site | Recruiting |
Crestview Hills, Kentucky, United States, 41017 | |
Pfizer Investigational Site | Recruiting |
Louisville, Kentucky, United States, 40217 | |
United States, Ohio | |
Pfizer Investigational Site | Not yet recruiting |
Columbus, Ohio, United States, 43213 | |
Canada, Ontario | |
Pfizer Investigational Site | Recruiting |
Toronto, Ontario, Canada, M6J 3S3 | |
Pfizer Investigational Site | Recruiting |
Mississauga, Ontario, Canada, L5B 4M4 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A9001380 |
Study First Received: | June 24, 2008 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00705601 |
Health Authority: | United States: Food and Drug Administration |
Nonrestorative Sleep, Restorative Sleep Questionnaire Refinement |