NCT04326634

Brief Summary

The aim is to compare a programme of controlled exercises therapy vs a programme of non controlled exercises therapy in patients with sleep apnea

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 30, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

March 30, 2020

Status Verified

March 1, 2020

Enrollment Period

9 months

First QC Date

March 19, 2020

Last Update Submit

March 26, 2020

Conditions

Apnea, Sleep

Outcome Measures

Primary Outcomes (2)

  • awake episodes

    number of awake episodes

    immediately after treatment

  • awake episodes

    number of awake episodes

    3 months

Study Arms (2)

Controlled exercises Group

EXPERIMENTAL
Other: controlled exercisesOther: non controlled exercises group

Non controlled exercises Group

EXPERIMENTAL
Other: controlled exercisesOther: non controlled exercises group

Interventions

controlled exercisesOTHER

controlled exercises

Controlled exercises GroupNon controlled exercises Group
non controlled exercises groupOTHER

non controlled exercises

Controlled exercises GroupNon controlled exercises Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • sleep apnea

You may not qualify if:

  • neurologic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Central Study Contacts

Gema Serrano-Hernanz, PhD

CONTACT

669332986gema.serrano.hernanz@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 19, 2020

First Posted

March 30, 2020

Study Start

September 1, 2020

Primary Completion

June 1, 2021

Study Completion

December 1, 2021

Last Updated

March 30, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share