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

NCT00705601 | Terminated

• 1 other identifier: A9001380
• Study Type: observational
• Target: 64
• Locations: 2 countries
• Sites: 13

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

Conditions

Nonrestorative Sleep

Keywords

Nonrestorative Sleep, Restorative Sleep Questionnaire Refinement

Outcome Measures

Primary Outcomes (3)

• Once subjects identified, a series of focus group sessions will be held to identify concepts, themes and items relevant to Nonrestorative Sleep.

  monthly

• 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

• 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 Outcomes (3)

• 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 assessments to characterize the functional impact of insomnia including Nonrestorative Sleep include additional PSG (polysomnography) variables.

  nightly

• 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

Study Arms (1)

1

Procedure: PSG

Interventions

PSG PROCEDURE

PSG (polysomnography) for adaptation night, day 2 evening, and day 3 evening--used to identify suitable Nonrestorative Sleep candidates to participate in focus groups.

1

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (13)

Pfizer Investigational Site

Fountain Valley, California, 92708, United States

Location

Pfizer Investigational Site

Pasadena, California, 91106, United States

Location

Pfizer Investigational Site

San Diego, California, 92121, United States

Location

Pfizer Investigational Site

Tustin, California, 92780, United States

Location

Pfizer Investigational Site

Miami, Florida, 33143, United States

Location

Pfizer Investigational Site

Pembroke Pines, Florida, 33026, United States

Location

Pfizer Investigational Site

Atlanta, Georgia, 30342, United States

Location

Pfizer Investigational Site

Overland Park, Kansas, 66212, United States

Location

Pfizer Investigational Site

Crestview Hills, Kentucky, 41017, United States

Location

Pfizer Investigational Site

Louisville, Kentucky, 40217, United States

Location

Pfizer Investigational Site

Columbus, Ohio, 43213, United States

Location

Pfizer Investigational Site

Mississauga, Ontario, L5B 4M4, Canada

Location

Pfizer Investigational Site

Toronto, Ontario, M6J 3S3, Canada

Location

Related Publications (1)

• 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.

  PMID: 25024650 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2008
• First Posted: June 26, 2008
• Study Start: August 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: March 4, 2019

Record last verified: 2019-02

Locations

US (11); CA (2)