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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date May 2021
Source Institute of OM Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Orgasmic Meditation
Orgasmic Meditation (OM) is a form of meditation that increases bodily awareness during structured, partnered female genital stimulation over a 15-minute period.

Locations

Country Name City State
United States Institute of OM Foundation Santa Rosa California

Sponsors (1)

Lead Sponsor Collaborator
Institute of OM Foundation

Country where clinical trial is conducted

United States, 

Outcome

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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