Insomnia Behavioral Intervention Study

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT05301543
Status
Recruiting
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Conditions

  • Chronic Insomnia

Eligibility Criteria

Sex
ALL
Age
55 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Experimental: Behavioral approach 1 — BEHAVIORAL
    Includes changing sleep habits and cognitions around sleep from a mental level
  • Comparator: Behavioral approach 2 — BEHAVIORAL
    Includes changing sleep habits and awarenes of sleep from a perception level

Study Details

This randomized pilot study (n=20) explores the effects of a behavioral intervention, that includes sleep hygiene improvements, in long-term users of sleeping pills, aiming to alleviate or stabilize symptoms of insomnia, monitor and decrease sleeping pill usage. Adherence will be monitored by an optional smartphone application.

Key Dates

Start date
Jan 10, 2022
Status verified
Jul 2025
Primary completion
Apr 8, 2027
Completion
May 20, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Behavioral approach 1
    This includes sleep hygiene and other elements to serve as an experimental arm; subjects will receive a clinically proven therapeutic intervention.
  • Active Comparator: Behavioral approach 2
    This includes sleep hygiene and other elements to serve as an active comparator; subjects will receive a clinically proven therapeutic intervention.

Primary Outcome Measure

Sleep Pill Dosage [ Time Frame: 28-day follow-up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Pennsylvania School of MedicinePhiladelphiaPennsylvania19104
Alex J Mathew
[email protected]
215-596-9715
Nalaka Gooneratne, MD, MSc. (PRINCIPAL_INVESTIGATOR)

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By research site
University of Pennsylvania School of Medicine· Philadelphia, PA

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