Treating Disrupted Sleep in Individuals With Inflammatory Bowel Disease

Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02162862
• Other study ID #: CCFA 13050045
• Status: Completed
• Phase: Phase 4
• First received: June 11, 2014
• Last updated: May 22, 2017
• Start date: July 2013
• Est. completion date: June 30, 2016

Study information

• Verified date: May 2017
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: June 30, 2016
• Est. primary completion date: June 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 30 Years

Eligibility

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)

Related Conditions & MeSH terms

• Dyssomnias
• Fatigue
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Parasomnias
• Sleep Disturbance
• Sleep Wake Disorders

Intervention

Behavioral:
• Behavioral Counseling

Drug:
• bupropion-SR

Locations

Country	Name	City	State
United States	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	Presbyterian University Hospital of UPMC	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Crohn's and Colitis Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Multidimensional Fatigue Inventory (MFI)	MFI score range is 0-100. Higher score indicates higher level of fatigue.	Baseline (week 0) to end of study (week 14)
Primary	Epworth Sleepiness Scale (ESS)	ESS scoring range from 0-24 with higher score indicating increased likelihood for sleepiness or dozing.	Baseline (week 0) to end of study (week 14)
Secondary	Change in Baseline in Pittsburgh Sleep Quality Index (PSQI)	PSQI score range is 0-21 with higher score indicating greater sleep disturbance.	Baseline (week 0) to end of study (week 14)