Assessment of a Behavioral Sleep Program in a Population With Sleep Disturbances
Public ClinicalTrials.gov record NCT05872672. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Assessment of a Behavioral Sleep Program Using Subjective and Objective Measures of Sleep Quality in a Population With Sleep Disturbances
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Sleep disturbances are considered a significant public health concern. The prevalence of disrupted sleep among US adults has increased to alarming levels. Around 70 million Americans suffer from a sleep disturbance. Reduced sleep and poor sleep quality have been linked to cardiovascular disease, increased risk for obesity, hypertension, heart attack, and stroke. Sleep disturbances are characterized by dissatisfaction with sleep quality or sleep quantity, which may be associated with difficulties initiating sleep, difficulties maintaining sleep, or early-morning awakenings with an inability to return to sleep. Sleep disturbances including insomnia can be treated with pharmacological treatments. However, individuals often report adverse side effects. Increasing attention has therefore been paid to behavioral and psychological interventions, such as cognitive behavioral therapy and mindfulness. The study will assess a smartphone-based sleep program by Headspace Health that combines cognitive behavioral therapy for insomnia (CBTi) and mindfulness concepts to minimize nocturnal symptoms and waking consequences associated with sleep disturbances. The study aims to test the effectiveness of the Headspace Health Sleep Program on self-reported outcomes related to sleep quality. A secondary aim is to test objective measures of sleep quality using actigraphy. The Headspace Health Sleep Program is an 18 day program based on CBTi, which includes the following intervention components: 1) a sleep diary to monitor sleep and associated factors; 2) cognitive interventions to address maladaptive thoughts related to sleep; 3) behavioral interventions to address maladaptive behaviors related to sleep (e.g., sleep hygiene, stimulus control, and sleep restriction); 4) de-arousal techniques (e.g., mindfulness, breathing, and muscle relaxation exercises).
Study identification
- NCT ID
- NCT05872672
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 132 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2023
- Primary completion
- Apr 14, 2024
- Completion
- Apr 14, 2024
- Last update posted
- Jun 4, 2024
2023 – 2024
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Fralin Biomedical Research Institute at VTC | Roanoke | Virginia | 24016 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05872672, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 4, 2024 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05872672 live on ClinicalTrials.gov.