Ensuring Access to Optimal Therapy in CF – The ENACT study (neuropsych prospective Aim 3) 

Study Description

Researchers at Arkansas Children's are doing a study to better understand how CFTR modulator medicines may affect mental and physical health.

Who can join?

You may be able to join if you: 

• Have been diagnosed with cystic fibrosis (CF) and your CF gene type is known
• Are 3 years old or older
• Have been taking a CFTR modulator medicine as prescribed and have not stopped taking it in the last 14 days. You should also not plan to stop taking it before your first study visit.
• Have stable lung health. This means you have not had a major drop in lung function or needed extra antibiotics for a lung problem in the past 4 weeks.

You may qualify for one or both studies:

Study A (One-Time Visit)

You may join if you:

• Have no side effects, or
• Have had one or more side effects after starting a CFTR modulator, such as:
  • Anxiety or depression
  • Trouble thinking or "brain fog"
  • Problems paying attention
  • Trouble sleeping (insomnia)
  • Hallucinations
  • Other symptoms you have noticed

Study B (Up to 6 Visits)

You may join if you have had one or more side effects after starting a CFTR modulator, such as:

• Anxiety or depression
• Trouble thinking or "brain fog"
• Problems paying attention
• Trouble sleeping (insomnia)
• Hallucinations
• Other symptoms you have noticed

What will happen during the study?

Adults and children can choose to join:

• Study A only
• Study B only
• Or both studies

Study A

• One study visit that includes:
  • Questions about your health
  • A blood sample
  • Tests of your mood and thinking
  • A breathing test (spirometry)
  • A sweat chloride test

Study B

• Up to 6 study visits, about 4 to 12 weeks apart.
• Each visit includes:
  • Questions about your health
  • A blood sample
  • Tests of your mood and thinking
  • A breathing test (spirometry)
  • A sweat chloride test

The study team will explain everything before you decide if you want to join. They will also answer any questions you have.

Participants can receive up to $90 for each completed study visit. If you have travel costs related to the study, you may also be reimbursed.

Contact Information:

Michelle Gillespie, MM, CRS
Research Coordinator
501-364-3377
GillespieM@archildrens.org