Nonrestorative Sleep RSQ (Restorative Sleep Questionnaire) Development-- Methodology Study

Nonrestorative Sleep Clinical Trial

Official title:

Refinement Of Patient Reported Outcomes Instruments In Subjects With Insomnia Characterized By Nonrestorative Sleep

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00705601
• Other study ID #: A9001380
• Status: Terminated
• Start date: August 2008
• Est. completion date: January 2009

Study information

• Verified date: February 2019
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 64
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• 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.

Locations

Country	Name	City	State
Canada	Pfizer Investigational Site	Mississauga	Ontario
Canada	Pfizer Investigational Site	Toronto	Ontario
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Columbus	Ohio
United States	Pfizer Investigational Site	Crestview Hills	Kentucky
United States	Pfizer Investigational Site	Fountain Valley	California
United States	Pfizer Investigational Site	Louisville	Kentucky
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Overland Park	Kansas
United States	Pfizer Investigational Site	Pasadena	California
United States	Pfizer Investigational Site	Pembroke Pines	Florida
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	Tustin	California

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Once subjects identified, a series of focus group sessions will be held to identify concepts, themes and items relevant to Nonrestorative Sleep.		monthly
Primary	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.		nightly
Primary	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)].		nightly
Secondary	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.		nightly
Secondary	Secondary assessments to characterize the functional impact of insomnia including Nonrestorative Sleep include additional PSG (polysomnography) variables.		nightly
Secondary	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.		monthly

External Links

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