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

Pfizer

Status: Terminated

Conditions: Nonrestorative Sleep

Treatments: Procedure: PSG

Study type: Observational

Funder types: Industry

Identifiers

NCT00705601

A9001380

Details and patient eligibility

About

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

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

64 participants in 1 patient group

1

Treatment:

Procedure: PSG