Nonrestorative Sleep RSQ (Restorative Sleep Questionnaire) Development-- Methodology Study
NCT00705601
ABOUT THIS STUDY
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- Subjects who self report nonrestorative sleep but no problems either getting to sleep or staying asleep
- Complaints of significant distress or impairment in social, occupational, or other important areas of functioning during daytime for at least 3 nights per week
- Self reports sWASO (Wake after sleep onset) for <45 minutes for past 3 months, self reports LPS (latency to persistent sleep onset ) for <20 minutes for past 3 months (then neither PSG (polysomnography) screening night showing WASO >45min, or LPS > 20 minutes)
- Customary bedtime betw. 9 pm and midnight and rise between 4 and 9 AM
- Psychiatric disease or disorder as determined by current administration of the MINI
(Mini International Neuropsychiatric Interview)
- History or presence of any breathing-related sleep disorder, narcolepsy, or any other
dyssomnias or any parasomnia, or restless legs syndrome MAP > 0.5 at screening
- History or presence of any medical or neurological condition that could interfere with
sleep (chronic pain, Restless leg, etc)
- Current use of meds wth known psychotropic effects or known or suspected effects on
sleep
- Alcohol or substance abuse (unless in remission for at least a year
- Excessive caffeine use (or any use after 6 pm for at least 3 months
- Regular napping or any naps after 6 pm
- Excessive cigarette or cigar smoking over the last 3 months
- no participation in an investigational new drug study within 30 days of screening, and
no previous participation in a study of PD200390
- No night or rotating shift work
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Descriptive Information | ||||
---|---|---|---|---|
Brief Title | Nonrestorative Sleep RSQ (Restorative Sleep Questionnaire) Development-- Methodology Study | |||
Official Title | Refinement Of Patient Reported Outcomes Instruments In Subjects With Insomnia Characterized By Nonrestorative Sleep | |||
Brief Summary | 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 | |||
Detailed Description | Study was terminated on January 20, 2009 due to portfolio decision by Pfizer to discontinue further investigation of PD200390 for non-restorative sleep. The decision was not based on any safety concerns. | |||
Study Type | Observational | |||
Study Design | Not Provided | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Not Provided | |||
Study Population | Not Provided | |||
Condition | Nonrestorative Sleep | |||
Intervention | 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. | |||
Study Groups/Cohorts | 1
Intervention: Procedure: PSG | |||
Publications * | Drake CL, Hays RD, Morlock R, Wang F, Shikiar R, Frank L, Downey R, Roth T. Development and evaluation of a measure to assess restorative sleep. J Clin Sleep Med. 2014 Jul 15;10(7):733-41, 741A-741E. doi: 10.5664/jcsm.3860. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status | Terminated | |||
Actual Enrollment | 64 | |||
Original Estimated Enrollment | 65 | |||
Actual Study Completion Date | January 2009 | |||
Actual Primary Completion Date | January 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender |
| |||
Ages | 18 Years to 64 Years (Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Canada, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT00705601 | |||
Other Study ID Numbers | A9001380 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor | Pfizer | |||
Collaborators | Not Provided | |||
Investigators |
| |||
PRS Account | Pfizer | |||
Verification Date | February 2019 |