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Feasibility of Non-pharmacological Insomnia Therapy in People Living With HIV

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01804907
First received: March 4, 2013
Last updated: May 19, 2014
Last verified: April 2014

March 4, 2013
May 19, 2014
March 2012
December 2012   (final data collection date for primary outcome measure)
Sleep Efficiency [ Time Frame: Week 1, 2,3, and 4 ] [ Designated as safety issue: No ]
Patients evaluated weekly for change in sleep efficiency.
Same as current
Complete list of historical versions of study NCT01804907 on ClinicalTrials.gov Archive Site
  • Adherence to HAART [ Time Frame: Week 1, 2,3, and 4 ] [ Designated as safety issue: No ]
    Evaluated once weekly for changes in medication adherence.
  • Fatigue [ Time Frame: Week 1, 2,3, and 4 ] [ Designated as safety issue: No ]
    Changes in reported fatigue levels measured weekly, via the Paper Fatigue Scale (PFS), and the HIV-Related Fatigue Scale (HRFS).
Same as current
Not Provided
Not Provided
 
Feasibility of Non-pharmacological Insomnia Therapy in People Living With HIV
Not Provided

To establish with a prospective randomized placebo-controlled study the feasibility of allied-health personnel-administered cognitive behavioral insomnia therapy (CBTI) as a means of improving HIV/AIDS treatment adherence.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Insomnia
  • Sleep Efficiency
  • Behavioral: Cognitive Behavioral Therapy
  • Behavioral: Behavioral Modification
  • Experimental: CBT
    Cognitive Behavioral Therapy
    Intervention: Behavioral: Cognitive Behavioral Therapy
  • Sham Comparator: Behavioral Modification
    Standard sleep hygiene education/desensitization therapy
    Intervention: Behavioral: Behavioral Modification
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
36
June 2014
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • provide documentation of HIV seropositivity, and have been on current HAART (Highly Active AntiRetroviral Therapy) or antiretroviral regimen without any foreseeable reason to discontinue the HAART during the course of the study;
  • males or females age 18-75 years of age;
  • ≥3 month history of insomnia meeting standard psychiatric criteria for insomnia based on DSISD;
  • sleep onset latency (SOL) and/or wake after sleep onset (WASO) greater than 30 minutes, with a corresponding sleep time of less than 6.5 hours at least 3 nights per week (as measured by the 7-day sleep diary);
  • be able to read, understand, and sign an informed consent form before entering into the study and must be willing to comply with all study procedures as well as to agree to participate for the entire study period.

Exclusion Criteria:

  • use of any medication with a significant effect on sleep/wake function within 5 half-lives of baseline or during the study including hypnotics, over-the-counter sleep aides, sedating antidepressants or sedating anxiolytics;
  • history or DSISD (Duke Insomnia Sleep Diagnostics) suggests sleep disorder other than insomnia (e.g., sleep apnea, narcolepsy, periodic leg movements, etc.), or have insomnia associated with circadian rhythm disturbances, such as night or rotating shift work or travel across more than four time zones in the 14 days before Initial Screening (Visit 1) or during the study;
  • clinically significant unstable medical or psychiatric condition, or have any clinically significant abnormal finding in physical examination, neurological assessment, or vital signs, as determined by the Investigator;
  • self reports typical consumption of more than five alcoholic beverages on a single day or greater than 14 alcoholic beverages weekly at Initial Screening (Visit 1);
  • have used any investigational drug within 30 days or five half-lives (whichever is longer) prior to Initial Screening (Visit 1), or plans to use an investigational drug during the study;
  • unable to give informed consent or comply with study procedures.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01804907
Pro00032846
No
Duke University
Duke University
Not Provided
Not Provided
Duke University
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP