Characteristics of Sleep Patterns in Young Adults With and Without Insomnia
Psychobiology and Treatment Response in Primary Insomnia
2 other identifiers
interventional
69
1 country
1
Brief Summary
This study will compare the symptoms, experiences, and laboratory sleep characteristics of young adults with and without insomnia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Feb 2002
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedResults Posted
Study results publicly available
March 30, 2016
CompletedMarch 30, 2016
February 1, 2016
6.2 years
September 12, 2005
May 26, 2009
February 29, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Pittsburgh Sleep Quality Index
Self-report measure of sleep quality developed at University of Pittsburgh by Daniel J. Buysse, M.D. The PSQI total score ranges from 0 to 21 with 0 being marvelous sleep and 21 being horrid sleep. The difference score, reported below, is the total score after at least 5 weeks of treatment in one of the three arms, minus the baseline total score. A negative score means that the sleep of the participant improved.
post treatment minus baseline assessment battery. This averaged 100 days.
Change in Diary Sleep Efficiency
The change in self-report sleep efficiency calculated from 7-day sleep diary (DSE): Sleep efficiency is the percent of (time spent asleep divided by the amount of time between good night time and final awakening). It ranges from 0 (no sleep at all) to 100 (asleep the second your head hits the pillow until you wake up in the morning and get out of bed). Participants report the time they go to bed, how long they think it takes them to fall asleep, how many minutes they are awake during the night, and then what time they finally wake up in the morning. These values are used to calculate the diary sleep efficiency for each night and then we averaged these across the 7 days of diary collected pre and post treatment. The values below are post treatment DSE minus pre treatment DSE. A positive number means that the DSE was higher (better) post treatment.
post treatment minus baseline. This averaged 69 days.
Secondary Outcomes (1)
Change in PSG Sleep Efficiency for the Second Night in the Sleep Lab at Each Timepoint
post treatment minus baseline PSG sleep studies. This averaged 70 days
Study Arms (3)
Zolpidem
EXPERIMENTALThe benzodiazepine receptor agonist (BzRA), zolpidem was given in an initial dose of 5 mg by mouth every night, 30 minutes prior to bedtime. The dose was increased to a maximum of 10 mg after the first week if there was no improvement in overall symptoms (CGI score of 4 or \>). The dose was decreased to 5 mg if side effects occurred.
Excitalopram
EXPERIMENTALThe antidepressant, escitalopram was initiated at 5 mg by mouth every night, 30 minutes prior to bedtime. If there were no side effects, the dose was increased every four days until the target dose of 20 mg (maximum dose) was reached by day 13. If significant side effects appeared, the highest tolerated dose was used.
Placebo
PLACEBO COMPARATORA placebo capsule was given with instructions to take it every night by mouth, 30 minutes prior to bedtime.
Interventions
The benzodiazepine receptor agonist (BzRA), zolpidem was given in an initial dose of 5 mg by mouth every night, 30 minutes prior to bedtime. The dose was increased to a maximum of 10 mg after the first week if there was no improvement in overall symptoms (CGI score of 4 or \>). The dose was decreased to 5 mg if side effects occurred.
The antidepressant, escitalopram was initiated at 5 mg by mouth every night, 30 minutes prior to bedtime. If there were no side effects, the dose was increased every four days until the target dose of 20 mg (maximum dose) was reached by day 13. If significant side effects appeared, the highest tolerated dose was used.
A placebo capsule was given with instructions to take it every night by mouth, 30 minutes prior to bedtime.
Eligibility Criteria
You may qualify if:
- Physically healthy
- Meets DSM-IV criteria for primary insomnia
- For subjects interested in PET study only: right-handedness
You may not qualify if:
- Currently taking antidepressants, antianxiety medications or medications for sleep disorders
- Currently experiencing symptoms of psychiatric disorders such as major depressive disorder, bipolar disorder, generalized anxiety disorder
- Significant or unstable acute or chronic medical conditions, such as seizure disorder, tumor, liver disease, active peptic ulcer disease, arthritis, irritable bowel disease
- Meets DSM-IV criteria for sleep apnea or periodic limb movement disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Western Psychiatric Institute and Clinic/ University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jean Miewald
- Organization
- University of Pittsburgh
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel J. Buysse, MD
University of Pittsburgh
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, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 15, 2005
Study Start
February 1, 2002
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
March 30, 2016
Results First Posted
March 30, 2016
Record last verified: 2016-02
Data Sharing
- IPD Sharing
- Will share
To gain access to data, researchers must submit a description of their project to the Principal Investigator, including the investigator's personal identification and institutional affiliation, a current CV, qualifications, duration of the proposed research, source of funding, and a conflict of interest statement. The protocol must include study aims, background and significance, methods and types of analysis, and a description of the data requested. Once approved, the investigator must complete a University of Pittsburgh IRB exempt research application form and document completion of a responsible conduct of research program. Data will be prepared by an 'honest broker' from the data management staff of the project. This person will complete the honest broker certification form required by our IRB. Data will be provided as a SAS data set, and will not include information that could identify individual research participants or that the original consent form expressly forbade.