- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07618104
Pornography Abstinence and Nocturnal Erections in Adult Men
A Real-World Observational Study Evaluating the Effects of 30 Days of Pornography Abstinence on Nocturnal Penile Tumescence, Sexual Function, and Well-Being in Adult Men
The effects of pornography use on male sexual health remain uncertain, with mixed findings across existing literature and substantial variability at the individual level. This observational study is designed to help participants evaluate how a 30-day period of pornography abstinence affects their own sexual health and well-being, with a specific focus on nocturnal penile tumescence as a physiological biomarker.
Participants will complete a short baseline observation period during which they maintain their usual pornography consumption patterns, followed by a 30-day abstinence period. Objective nocturnal erection data will be collected using a connected wearable device, alongside validated self-report questionnaires assessing erectile function, sexual desire, mood, energy, and emotional well-being. Participants serve as their own control, allowing for within-person comparisons of outcomes before and during the abstinence period.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This single-arm, real-world observational study evaluates the association between pornography abstinence and changes in nocturnal penile tumescence, sexual function, and psychosocial outcomes in adult men.
During an initial baseline phase, participants continue their typical pornography use while collecting objective nocturnal erection data and completing baseline questionnaires. Participants then enter a 30-day abstinence period, during which they attempt to refrain from pornography use. Abstinence adherence is self-reported, with lapses logged as observational data rather than protocol violations.
Nocturnal penile tumescence is assessed nightly using the Adam Sensor, a non-invasive wearable device that measures changes in penile circumference during sleep. Additional outcomes are assessed using validated questionnaires administered at baseline and at weekly intervals. The study is exploratory and signal-detecting in nature and is not designed to establish causality.
Study Design
Study Type: Observational
Study Design: Single-arm, within-participant comparison
Time Perspective: Prospective
Masking: None (Open Label)
Primary Purpose: Health outcomes assessment / signal detection
Additional information can be found at the study recruitment landing page here: https://app.efforia.com/30-day-tv-abstinence-challenge/
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Matthew Amsden
- Número de teléfono: (646) 679-2479
- Correo electrónico: help@efforia.com
Ubicaciones de estudio
-
-
New York
-
New York, New York, Estados Unidos, 10003
- Reclutamiento
- Efforia
-
Contacto:
- Matthew Amsden
- Número de teléfono: (646) 679-2479
- Correo electrónico: help@efforia.com
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Adult males of legal age of consent
- Willingness to attempt pornography abstinence
- Ability to use a wearable device during sleep
- Ability to complete electronic surveys
- Willingness to purchase the study device
Exclusion Criteria:
- Have a history of significant sexual dysfunction requiring active medical treatment
- Have current or uncontrolled mental health disorders
- Have a history of addictive behaviors that may be exacerbated by abstinence
- Are undergoing hormonal therapy or treatment affecting sexual function
- Are experiencing unstable interpersonal or relationship stressors
- Have significant concerns about privacy related to sexual health data
- Have cultural or religious considerations that could cause distress
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Single Arm longitudinal where participants act as their own control
|
Participants will attempt to abstain from all pornography use for 30 consecutive days.
Any deviations from abstinence are self-reported and logged for contextual analysis.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Nocturnal Penile Tumescence
Periodo de tiempo: Baseline Day to Day 38
|
Measure: Adam Sensor - Nocturnal Erection Tracking Description: Objective measurement of nocturnal penile tumescence, Frequency/Time nocturnal erections per night |
Baseline Day to Day 38
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Erectile Function
Periodo de tiempo: Baseline to Day 38 after intervention
|
Measure: International Index of Erectile Function (IIEF-15) Scale Range: 5-75 (higher scores indicate better erectile and sexual function) Description: Assesses erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. |
Baseline to Day 38 after intervention
|
|
Change in Sexual Desire
Periodo de tiempo: Baseline to Day 38 after intervention
|
Measure: Sexual Desire Inventory-2 (SDI-2) Scale Range: 0-112 (higher scores indicate greater sexual desire) Description: Measures both dyadic and solitary sexual desire. |
Baseline to Day 38 after intervention
|
|
Change in Pornography Consumption Patterns
Periodo de tiempo: Baseline to Day 38 after intervention
|
Measure: Weekly Pornography Consumption Survey (custom self-report) Scale: Frequency and duration categories (ordinal) Description: Tracks self-reported pornography use and abstinence adherence. |
Baseline to Day 38 after intervention
|
|
Change in Mood, Energy, and Emotional Well-Being
Periodo de tiempo: Baseline to Day 38 after intervention
|
Measure: Weekly Self-Assessment Check-In (custom) Scale: 1-10 Likert-type scales (higher scores indicate more favorable states) Description: Assesses perceived mood, mental clarity, energy level, and emotional resilience. |
Baseline to Day 38 after intervention
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 38321
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .