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Search / Trial NCT06475378

Enhancing Sleep Onset: the Power of Tactile Breath Pacer in Cognitive Behavioral Therapy for Insomnia

Launched by VRIJE UNIVERSITEIT BRUSSEL · Jun 25, 2024

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to help people with chronic insomnia, which is a condition where individuals have trouble falling or staying asleep. The researchers want to see if combining traditional therapy known as Cognitive Behavioral Therapy for Insomnia (CBT-I) with a special breathing device called Moonbird can improve sleep. In this study, 72 participants will be randomly divided into three groups: one will receive standard CBT-I, another will get CBT-I along with the Moonbird breathing device, and the last group will receive standard CBT-I with a non-working version of the device. The study aims to understand which treatment works best for improving sleep.

To be eligible for this trial, participants must be diagnosed with chronic insomnia and be between the ages of 65 and 74. Those who are underage or have other untreated sleep disorders will not be included. Throughout the trial, participants will be assessed by sleep psychologists at UZ Brussel, who will conduct various measurements and questionnaires. They will have their sleep monitored before and after treatment, with follow-ups scheduled right after treatment and three months later. This study will help determine if the new technology can effectively support sleep therapy.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients must be diagnosed with chronic insomnia.
  • Exclusion Criteria:
  • Underaged patients and patients with untreated comorbid (sleep) disorders will be excluded from the study.

About Vrije Universiteit Brussel

The Vrije Universiteit Brussel (VUB) is a distinguished research university located in Brussels, Belgium, known for its commitment to innovative education and cutting-edge research across various disciplines. As a clinical trial sponsor, VUB actively engages in advancing medical knowledge and improving patient care through rigorous scientific investigations. The university fosters collaborations with healthcare institutions and industry partners, ensuring that its clinical trials adhere to the highest ethical standards and regulatory requirements. VUB's research initiatives are driven by a multidisciplinary approach, leveraging expertise from fields such as medicine, health sciences, and biomedical engineering to address pressing health challenges and contribute to the development of novel therapies.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported