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Treating Disrupted Sleep in Individuals With Inflammatory Bowel Disease

Information source: University of Pittsburgh
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Sleep Disturbance; Fatigue; Inflammatory Bowel Disease

Intervention: Behavioral Counseling (Behavioral); bupropion-SR (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of Pittsburgh

Official(s) and/or principal investigator(s):
Eva Szigethy, MD, PhD, Principal Investigator, Affiliation: University of Pittsburgh

Overall contact:
Eva Szigethy, MD, PhD, Phone: 412-692-8147, Email: szigethye@upmc.edu

Summary

The purpose of this study is to determine if either a targeted type of talk therapy (Phase I) or medication, Wellbutrin, (Phase II) improve sleep disturbance and/or fatigue in individuals with Inflammatory Bowel Disease (IBD).

Clinical Details

Official title: Treating Disrupted Sleep in Individuals With Inflammatory Bowel Disease: A Novel Adjunctive Therapy for Chronic Inflammatory Illness

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Change from baseline in Multidimensional Fatigue Inventory (MFI)

Epworth Sleepiness Scale (ESS)

Secondary outcome: Change in Baseline in Pittsburgh Sleep Quality Index (PSQI)

Detailed description: The present study, sponsored by the Crohn's and Colitis Foundation of America, intends to provide information about the feasibility and effectiveness of treatments designed to lessen fatigue and improve sleep among youth with Crohn's disease (CD). Obtaining good sleep is vital in leading a healthy life. For youth with Inflammatory Bowel Disease (IBD), good sleep is key as patients are psychically and psychologically developing and maturing. Previous work suggests that 42% of youth with CD experience poor sleep: difficulty falling asleep, disruption in sleep, early morning awakening, or an absence of feeling refreshed after sleep. Poor sleep can negatively affect ones physical health, mental health, and stress

level - each minimizing ones quality of life.

Participants in the study range from 15-30 years old, live with CD, and experience sleep disturbances, targeting 100 participants. Additionally, a healthy control group, 30 participants, is included for comparison. The study contains two phases and takes place over a 12-week period. Phase one involves partaking in 3-8 sessions of Brief Behavioral Therapy for Sleep in IBD (BBTS-I) with study clinician. The treatment teaches self-management techniques and sleep interventions through self-hypnosis/relaxation and reflection. After the treatment, participants are reevaluated. Those who respond well to the treatment are offered 1-2 booster sessions, those who do not show improvement move on to phase two. In phase two, participants are offered an 8-week course of bupropion-sustained release (BUP-SR). BUP-SR reduces fatigue, depression, and inflammation, and enhances REM sleep. The prescribed dosage will increase from 100mg to 300 mg (150 mg 2x a day). Participant's characterization measures are assessed at the start, midpoint, and finish of the study to measure changes in sleep, fatigue, and mood. Also at these times, blood work is done in hopes of gaining an understanding of the cause of CD. At each of the three assessments, participants are asked to wear a wristwatch device for 7 days that records: total sleep time, wakefulness, and daytime information on napping and sleep hygiene. In addition, participants are asked to keep a brief sleep diary for a 7-day period. This study hopes to provide new treatments to increase the quality of life, primarily by improving sleep in patients with CD.

Eligibility

Minimum age: 15 Years. Maximum age: 30 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- IBD Group:

- Biopsy confirmed Crohn's Disease

- Qualifying scores on Multidimensional Fatigue Inventory and Pittsburgh Sleep

Quality Index

- Healthy Volunteer Group:

- Does not meet any exclusion criteria

Exclusion Criteria:

- IBD Group:

- Meeting criteria for active alcohol or substance abuse or dependence

- Current ongoing treatment with Wellbutrin

- Females who are pregnant or plan to become pregnant within three months

- Sleep disorder such as apnea, restless leg syndrome or use of Continuous

positive airway pressure therapy (C-PAP)/Bilevel positive airway pressure (Bi-PAP)

- Current IBD flare requiring hospitalization with intravenous steroid treatment

- Other acute medical conditions or a history of chronic inflammatory condition

other than IBD

- Hemoglobin <10 with age and gender adjustments

- History of seizure disorder

- Acute infection within seven days

- Healthy Volunteer Group:

- History or current episode of psychiatric disorder by Diagnositic and

Statistical Manual (DSM-IV)

- Current ongoing treatment with psychoactive medications

- Medications for sleep in previous two weeks

- Females who are pregnant or plan to become pregnant within three months

- History of IBD, epilepsy, rheumatoid arthritis, lupus

- Sleep disorder such as apnea, restless leg syndrome or use of Continuous

positive airway pressure therapy (C-PAP)/Bilevel positive airway pressure (Bi-PAP)

Locations and Contacts

Eva Szigethy, MD, PhD, Phone: 412-692-8147, Email: szigethye@upmc.edu

Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania 15224, United States; Recruiting
David M Rizzo, MSW, Phone: 412-692-3184, Email: rizzodm@upmc.edu
Eva Szigethy, MD, PhD, Principal Investigator
David Benhayon, MD, Ph D, Sub-Investigator
David Keljo, MD, Ph D, Sub-Investigator

Presbyterian University Hospital of UPMC, Pittsburgh, Pennsylvania 15213, United States; Recruiting
David M Rizzo, MSW, Phone: 412-692-3184, Email: rizzodm@upmc.edu
Eva Szigethy, MD, PhD, Principal Investigator
Jana Al-Hashash, MD, MPH, Sub-Investigator
Anne Germain, Ph D, Sub-Investigator
Francis Lotrich, MD, Ph D, Sub-Investigator
Miguel Regueiro, MD, Sub-Investigator
Ada Youk, Ph D, Sub-Investigator

Additional Information

Starting date: July 2013
Last updated: June 11, 2014

Page last updated: August 23, 2015

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