NCT00156533

Brief Summary

We want to assess whether "how and when" one takes sleep medication results in similar or different outcomes with respect to symptom relief. We also want to know whether taking medication for a period of time provides continued benefit once the medication is stopped.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2005

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
5.3 years until next milestone

Results Posted

Study results publicly available

May 16, 2013

Completed
Last Updated

November 20, 2015

Status Verified

October 1, 2015

Enrollment Period

2.9 years

First QC Date

September 7, 2005

Results QC Date

October 10, 2011

Last Update Submit

October 21, 2015

Conditions

InsomniaPrimary InsomniaPsychophysiologic Insomnia

Keywords

InsomniaSleepzolpidemAmbienHypnotics

Outcome Measures

Primary Outcomes (1)

  • Sleep Latency (SL)

    Number of subjects with any reduction in SL (time to fall asleep in minutes)at post-tx compared to baseline where mean SL = mean of daily values for one week calculated from sleep diary values.

    Baseline and Post-treatment (12wks)

Secondary Outcomes (1)

  • Wake After Sleep Onset (WASO)

    Baseline and Post-Treatment (12 weeks)

Study Arms (4)

Placebo

PLACEBO COMPARATOR

QHS dosing with placebo (i.e. nightly dose)

Drug: Sugar Pill

QHS Zolpidem

ACTIVE COMPARATOR

QHS dosing with 10mg of zolpidem (i.e. nightly dose)

Drug: Zolpidem

Intermittant Zolpidem

EXPERIMENTAL

Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed

Drug: Zolpidem

Control

NO INTERVENTION

Monitor only condition (no placebo, no drug).

Interventions

ZolpidemDRUG

10 mg of Zolpidem

Also known as: Ambien
Intermittant ZolpidemQHS Zolpidem
Sugar PillDRUG
Placebo

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Ages 25 - 55
  • a stable sleep/wake schedule with a preferred sleep phase between 10:00 p.m. and 8:00 a.m.
  • Patients with Primary Insomnia will meet diagnostic criteria for Psychophysiologic Insomnia according to the International Classification of Sleep Disorders manual (ICSD).
  • complaint of disturbed sleep must have the following characteristics: \>30 minutes to fall asleep, and/or \>30 minutes wake after sleep onset time, a total sleep time of no more than 6.5 hours (or a sleep efficiency of less than 85%), a problem frequency of \>4 nights/ week and a problem duration \>6 months.

You may not qualify if:

  • Unstable medical or psychiatric illness
  • Use of medication that may cause insomnia or may be reduce the effectiveness of zolpidem (e.g. selective serotonin reuptake inhibitors(SSRI's), steroids, bronchodilators, calcium channel blockers, beta blockers, etc.)
  • symptoms suggestive of sleep disorders other than insomnia
  • polysomnographic data indicating sleep disorders other than insomnia
  • Evidence of active illicit substance use or fitting criteria for alcohol abuse or dependence
  • inadequate language comprehension
  • pregnancy
  • first-degree relatives with bipolar disorder or schizophrenia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester Sleep Research Laboratory

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

ZolpidemSugars

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCarbohydrates

Limitations and Caveats

About 25% of the target sample was obtained. As a result our capacity to detect trends and to calculate effect sizes was greatly diminished. Accordingly, our observations must be very limited in scope.

Results Point of Contact

Title
Wilfred Pigeon
Organization
University of Rochester
wilfred_pigeon@urmc.rochester.edu
585 275-3374

Study Officials

  • Michael L Perlis, Ph.D.

    University of Rochester

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Psychiatry

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 12, 2005

Study Start

March 1, 2005

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

November 20, 2015

Results First Posted

May 16, 2013

Record last verified: 2015-10

Locations

US(1)