Clinical trial Recruiting at 1 site Interventional Ages 65 and up

Nurse-guided app-based brief behavioral therapy for insomnia in older adults

Official title: The Effect of Nurse-Led Mobile APP-based Brief Behavioral Therapy for Insomnia in Older Adults: A Randomized Controlled Trial

Run by Taipei Medical University · NCT07842250 · Data updated 2026-11-12

Aging adults with insomnia will be asked to try a nurse-supported, smartphone app therapy for four weeks to see if it helps with sleep.

Quick facts

Study typeInterventional
Ages65 Years and up
SexAll
Enrollment60 (estimated)
SponsorTaipei Medical University
Academic / other
Locations1 site (Taipei)
StatusRecruiting
StartedAugust 31, 2026
Main results expectedJuly 31, 2027
Study endsAugust 31, 2027
Registry record updatedSeptember 25, 2026
Trial IDNCT07842250 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults 65+ with ISI ≥15 who own a smartphone and can use the app with or without assistance.

Probably not a fit

Patients who do not respond to behavioral sleep therapies or have untreated severe sleep apnea or other exclusions may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized trial tests a nurse-guided, app-based brief behavioral treatment for insomnia (BBTI) against face-to-face BBTI and a sleep-education control in adults aged 65 and older. Participants have an ISI score of 15 or higher and own a smartphone. Over four weeks, the app group receives nurse follow-up, the in-person group receives weekly nurse-delivered BBTI, and the control group receives sleep education materials. The study aims to determine whether digital, nurse-supported BBTI can achieve comparable sleep improvements to traditional therapy. Outcomes include changes in insomnia severity and related sleep parameters.

Why it matters

Potential benefit: If successful, older adults could access effective insomnia treatment through a convenient app with nurse support.

How similar studies have gone: Previous work suggests behavioral approaches can improve insomnia, with digital delivery showing promise when supported by clinicians.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Aged 65 years or older.
* An Insomnia Severity Index (ISI) score of 15 or higher, with the presence of insomnia-related symptoms such as difficulty initiating sleep, frequent nocturnal awakenings, or early morning awakening.
* Conscious and able to understand the study information.
* Ownership of a smartphone.
* Ability to operate the application and complete online questionnaires independently or with assistance from research staff or family.

Exclusion Criteria:

* Presence of severe psychiatric disorders with an unstable clinical condition.
* Diagnosed or suspected moderate to severe obstructive sleep apnea that has not been treated.
* Adjustment of sleep-related medication dosage within the past four weeks.
* Engagement in shift work or night work.
* Participants with acute cardiopulmonary diseases.
* Participants reporting a pain intensity score of ≥ 5 (on a 0-10 numeric rating scale) that interferes with sleep.

Where it's running

  • Taipei Medical University / Taipei Medical University Hospital
    Taipei, Taiwan
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.