Идёт набор NCT07477184

Sleep Well Firefighters: An App-based Program to Improve Sleep, Cognition, and Behavioral Health in Firefighters

Без фазы С лечением Sleep Health Stress Anxiety Physical Activity

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Sleep enhancement intervention, Standard of Care (Investigator Choice).
Кому может быть актуально: Состояния в реестре: Sleep Health, Stress, Anxiety, Physical Activity. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Intervention to Improve Sleep, Cognition, and Behavioral Health in Firefighters

Обзор

The purpose of this pilot study is to examine the feasibility and acceptability of an app-based sleep program designed to help firefighters improve their sleep.

Подробное описание

The purpose of this pilot study is to examine the feasibility and acceptability of an app-based sleep program designed to help firefighters improve their sleep. This trial will recruit firefighters working on the Central Coast of California. Upon completing screening procedures and an informed consent, participants will be asked to complete questionnaires related to sleep, behavioral health, and cognition and sleep patterns will be objectively assessed using research grade wrist-worn accelerometers. Participants will then be randomized to receive the Sleep Well intervention (mobile iOS app + monthly phone coaching; N=25) or a control condition (handout on sleep in firefighters; N=25). Over a three month study period, participants randomized to the Sleep Well intervention will be asked to 1) track their sleep, physical activity, eating, and stress; 2) complete weekly, in-app learning modules informed by social cognitive theory and cognitive behavioral therapy for insomnia covering topics such as sleep hygiene, bedtime routines, healthy eating and activity patterns, and managing stress; and 3) participate in three monthly coaching phone calls with a trained study interventionist. After the three month study period, all participants will be asked to repeat baseline assessments. Those in the Sleep Well intervention group will also be asked for user feedback. Quantitative data will inform feasibility of digitally delivered, behavioral sleep programming designed for firefighters. Findings will inform intervention strategies targeting healthy sleep behaviors to improve health and cognition in firefighters and guide the study protocol for a full-scale trial

Вмешательства

Поведенческое Sleep enhancement intervention
The Sleep Well Intervention Group will receive access to a digital Sleep Health App designed for Firefighters and will be asked to participate in monthly coaching phone calls aimed at improving their sleep health.
Поведенческое Standard of Care (Investigator Choice)
Basic Sleep Education materials that are Standard of Care and available to all Firefighters will be administered.

Первичные конечные точки

Recruitment capability [Срок оценки: From Baseline through Study Completion (12 weeks).]
Intervention Fidelity [Срок оценки: From Baseline through Study Completion (12 weeks).]
Intervention Adherence [Срок оценки: From Baseline (week 0) through Study Completion (12 weeks).]
Acceptability [Срок оценки: At Study Completion (12 weeks).]
Retention [Срок оценки: At Baseline (week 0) through Study Completion (week 12).]
Assessment procedures [Срок оценки: At baseline (week 0) through Study Completion (week 12).]
Adherence [Срок оценки: At baseline (week 0) through Study completion (week 12).]

Вторичные конечные точки (11)

Sleep, movement, and light exposure [Срок оценки: 7 days upon enrollment (Baseline; week 0) and 7 days prior to the end of the intervention (week 12).]
BMI [Срок оценки: At Baseline (week 0) and at Study Completion (week 12).]
Depressive symptoms [Срок оценки: At Baseline (week 0) and at Study Completion (week 12).]
Caffeine [Срок оценки: At Baseline (week 0) and at Study Completion (week 12).]
Anxiety [Срок оценки: At Baseline (week 0) and at Study Completion (week 12).]
Stress [Срок оценки: At Baseline (week 0) and at Study Completion (week 12).]
Quality of Life [Срок оценки: At Baseline (week 0) and at Study Completion (week 12).]
Psychomotor Vigilance [Срок оценки: At Baseline (week 0) and at Study Completion (week 12).]
Sleep Diary [Срок оценки: 7 days upon enrollment (Baseline; week 0) and 7 days prior to the end of the intervention (week 12).]
Epworth Sleepiness Scale (ESS) Score [Срок оценки: Baseline (Week 0) to Post-Intervention (Week 12)]
Pittsburgh Sleep Quality Index (PSQI) Global Score [Срок оценки: Baseline (Week 0) to Post-Intervention (Week 12)]

Критерии участия

Inclusion Criteria based on self report:

Current CalFire Wildfire firefighter in Central Coast region or City of San Luis Obispo Firefighter (non-volunteer and not a primarily administrator status)
English Speaking
Have an iPhone /iPad
Age >= 18
Self-reported interest in improving sleep functioning.