Clinical trial NCT00705601: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Nonrestorative Sleep
Keywords: Nonrestorative Sleep, Restorative Sleep Questionnaire Refinement
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-06-26
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Once subjects identified, a series of focus group sessions will be held to identify concepts, themes and items relevant to Nonrestorative Sleep.
timeFrame: monthly
measure: To begin to refine the development of the RSQ measure in subjects with Nonrestorative Sleep by generating item content pertaining to morning refreshment and uncovering problems in instrument administration in subjects with nonrestorative sleep.
timeFrame: nightly
measure: Identification of subjects with insomnia characterized by Nonrestorative Sleep only [assessed via LPS (latency to persistent sleep onset) and WASO (Wake after sleep onset) as determined by PSG (polysomnography)].
timeFrame: nightly
Secondary outcomes:
measure: Subjective measures include MAF (multidimensional assessment of fatigue), Sheehan Disability Scale, SF36v2, Endicott Work productivity scale (EWPS) Global impression of severity (CGIS) and the Profile of mood states.
timeFrame: nightly
measure: Secondary assessments to characterize the functional impact of insomnia including Nonrestorative Sleep include additional PSG (polysomnography) variables.
timeFrame: nightly
measure: After phase IIa of this study, a questionaire to be designed - Participants to be debriefed, and interviewed to assess the content validity of the questionnaire.
timeFrame: monthly
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: Pfizer Investigational Site
state: California
city: Pasadena
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Tustin
country: United States
facility: Pfizer Investigational Site
state: California
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Crestview Hills
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Mississauga
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.