Sleep Clinical Trial
Official title:
A Naturalistic, Longitudinal, Observational Study of Associations Between Frequency of Orgasmic Meditation Practice, Occurrence of Female Physiological Orgasm and Sleep Quality
NCT number | NCT04455971 |
Other study ID # | OMSLEEP |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 6, 2020 |
Est. completion date | April 15, 2021 |
Verified date | May 2021 |
Source | Institute of OM Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The primary purpose of this study is to use an observational design to examine whether the practice of orgasmic meditation (OM) is associated with app-based measures of sleep quality. A secondary purpose of this study is to examine whether the occurrence of physiological orgasm during OM practice is associated with app-based measures of sleep quality. It is hypothesized that the practice of OM will have a positive impact on sleep quality.
Status | Completed |
Enrollment | 46 |
Est. completion date | April 15, 2021 |
Est. primary completion date | April 15, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. =18 years old, males and females, no exclusion by race, ethnicity or sexual orientation 2. Experienced in OM practice ("experienced" defined as >10 OM sessions in lifetime) 3. Currently practicing OM and participating in =1 OM session per week on average 4. Willingness to calibrate the Sleep Cycle app and use it for 30 continuous nights 5. Ability to charge phone by bed overnight during sleep 6. Ability to place phone near the bed, such as on a nightstand table overnight during sleep Exclusion Criteria: 1. Inability to speak English |
Country | Name | City | State |
---|---|---|---|
United States | Institute of OM Foundation | Santa Rosa | California |
Lead Sponsor | Collaborator |
---|---|
Institute of OM Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Correlation between sleep quality and occurrence and frequency of OM sessions during the prior day | "Sleep quality" will be measured using the Sleep Cycle app | 30 days | |
Secondary | Correlation between sleep duration and occurrence and frequency of OM sessions during the prior day | "Sleep duration" will be measured using the Sleep Cycle app | 30 days | |
Secondary | Correlation between time to fall asleep and occurrence and frequency of OM sessions during the prior day | "Time to fall sleep" will be measured using the Sleep Cycle app | 30 days | |
Secondary | Correlation between sleep regularity and occurrence and frequency of OM sessions during the prior day | "Sleep regularity" will be measured using the Sleep Cycle app | 30 days | |
Secondary | Change in total sleep duration during nights following OM and nights following no OM | "Sleep duration" will be measured using the Sleep Cycle app | 30 days | |
Secondary | Change in time to fall asleep during nights following OM and nights following no OM | "Time to fall sleep" will be measured using the Sleep Cycle app | 30 days | |
Secondary | Change in sleep regularity during nights following OM and nights following no OM | "Sleep regularity" will be measured using the Sleep Cycle app | 30 days |
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