Sleep DisturbanceRPYNCT01366677
Yoga for Persons With Severe Visual Impairment
A study testing Yoga Intervention in people with Sleep Disturbance and Stress, run by Johns Hopkins University at 1 site in United States.
Trial summary
This study aims to provide novel information on the feasibility of yoga interventions for secondary symptoms related to severe vision loss, such as sleep disturbances, negative mood states, fall risk and balance. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disturbance, Stress, Anxiety
- What is being tested?
- Yoga Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18+
- Legal blindness (visual acuity worse than 20/200 but better than no/bare light perception, and/or visual field less than 20º, in the better eye)
- Any ocular disease diagnosis that is expected to remain relatively stable throughout a 3-6 month period
- Being healthy to the extent that participation yoga therapy would not exacerbate any existing disease conditions;
- Willingness to participate on a weekly basis for the 12-week intervention;
- Moderate to severe sleep disturbances, defined as ratings of 5 or greater on the PSQI
Who cannot join
- Significant changes to vision within the most recent 3-month period
- Inability to understand study procedures or communicate responses to visual stimuli in a consistent manner
- Clinically diagnosed or clinically significant sleep disorder (e.g., sleep apnea) or a medical or psychiatric condition (e.g., chronic pain) responsible for sleep complaints;
- Use of prescription sleep medication more than once a week for duration of the study;
- Use of other psychotropic medication;
- Current recipient of sleep disorder treatment;
- Consumption of more than 2-3 alcoholic beverages per day
- Smoking more than 10 cigarettes per day;
Trial locations and contacts
1 site in 1 country.
United States1 site
Lions Vision and Research Rehabilitation
Baltimore, Maryland, 21205
About this study
Official title: Development of a Yoga Intervention for Symptoms Related to Severe Visual Impairment
This study aims to provide novel information on the feasibility of yoga interventions for secondary symptoms related to severe vision loss, such as sleep disturbances, negative mood states, fall risk and balance. This information will be important for determining safe, cost-effective and reliable practices for the benefits of yoga as an alternative means for improved health and well-being. A yoga intervention that is integrative and evidence-based will benefit the blind population through effective treatments and prevention of secondary symptoms as well as serve to inform rehabilitation specialists, educators, and clinicians in the future.
Read the detailed description
This study aims to provide novel information on the feasibility of yoga interventions for secondary symptoms related to severe vision loss, such as sleep disturbances, negative mood states, fall risk and balance. This information will be important for determining safe, cost-effective and reliable practices for the benefits of yoga as an alternative means for improved health and well-being. A yoga intervention that is integrative and evidence-based will benefit the blind population through effective treatments and prevention of secondary symptoms as well as serve to inform rehabilitation specialists, educators, and clinicians in the future.
- Conditions
- Sleep Disturbance, Stress, Anxiety, Depression, Balance Impairment
- Being tested
- Yoga Intervention
- Medical subject headings
- Parasomnias, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga InterventionBehavioural
Also called Yoga, Ashtanga
Three yoga classes per week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Yoga Therapy | Experimental | Not described Receives: Behavioral: Yoga Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static Balance
Measures will be assessed at baseline (Week 0) and immediately after the 8-week intervention at Week 8.
Measured: Week 0 and Week 8.
Secondary outcomes (4)
Perceived Stress Scale
Measures will be assessed at baseline (Week 0) and immediately after the 8-week intervention at Week 8.
Measured: Week 0 and Week 8
Profile of Mood States - Short Form
Measures will be assessed at baseline (Week 0) and immediately after the 8-week intervention at Week 8.
Measured: Week 0 and Week 8
Exit Survey
The exist survey is administered immediately after the intervention during Week 8.
Measured: Week 8
Fear of Falling Questionnaire
Measures will be assessed at baseline (Week 0) and immediately after the 8-week intervention at Week 8.
Measured: Week 0 and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2011 (estimated)
- Study startAug 2010
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pamela Jeter, Johns Hopkins University
- Investigators
- Ava Bittner, PhD, OD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01366677
- Sponsor's protocol ID
- NA_00039032
- Acronym
- RPY
- Status last verified
- May 2014
- First submitted
- 2 Jun 2011
- Last updated
- 26 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Jeter PE, Haaz Moonaz S, Bittner AK, Dagnelie G. Ashtanga-Based Yoga Therapy Increases the Sensory Contribution to Postural Stability in Visually-Impaired Persons at Risk for Falls as Measured by the Wii Balance Board: A Pilot Randomized Controlled Trial. PLoS One. 2015 Jun 24;10(6):e0129646. doi: 10.1371/journal.pone.0129646. eCollection 2015.
PubMed 26107256
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Yoga Intervention for Symptoms Related to Severe Visual Impairment
- ClinicalTrials.gov ID
- NCT01366677
- Acronym / sponsor ID
- RPY / NA_00039032
- Conditions
- Sleep Disturbance, Stress, Anxiety, Depression, Balance Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 6 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to provide novel information on the feasibility of yoga interventions for secondary symptoms related to severe vision loss, such as sleep disturbances, negative mood states, fall risk and balance. This information will be important for determining safe, cost-effective and reliable practices for the benefits of yoga as an alternative means for improved health and well-being. A yoga intervention that is integrative and evidence-based will benefit the blind population through effective treatments and prevention of secondary symptoms as well as serve to inform rehabilitation specialists, educators, and clinicians in the future.
Detailed description
This study aims to provide novel information on the feasibility of yoga interventions for secondary symptoms related to severe vision loss, such as sleep disturbances, negative mood states, fall risk and balance. This information will be important for determining safe, cost-effective and reliable practices for the benefits of yoga as an alternative means for improved health and well-being. A yoga intervention that is integrative and evidence-based will benefit the blind population through effective treatments and prevention of secondary symptoms as well as serve to inform rehabilitation specialists, educators, and clinicians in the future.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Yoga Therapy | Experimental | Behavioral: Yoga Intervention |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18+
- Legal blindness (visual acuity worse than 20/200 but better than no/bare light perception, and/or visual field less than 20º, in the better eye)
- Any ocular disease diagnosis that is expected to remain relatively stable throughout a 3-6 month period
- Being healthy to the extent that participation yoga therapy would not exacerbate any existing disease conditions;
- Willingness to participate on a weekly basis for the 12-week intervention;
Key exclusion criteria (8 listed)
- Significant changes to vision within the most recent 3-month period
- Inability to understand study procedures or communicate responses to visual stimuli in a consistent manner
- Clinically diagnosed or clinically significant sleep disorder (e.g., sleep apnea) or a medical or psychiatric condition (e.g., chronic pain) responsible for sleep complaints;
- Use of prescription sleep medication more than once a week for duration of the study;
- Use of other psychotropic medication;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga InterventionAlso: Yoga, AshtangaThree yoga classes per week for 8 weeks. | Behavioural | Yoga Therapy |
Primary outcome
Static Balance
Time frame: Week 0 and Week 8.
Measures will be assessed at baseline (Week 0) and immediately after the 8-week intervention at Week 8.
4 secondary outcomes
Perceived Stress Scale
Time frame: Week 0 and Week 8
Profile of Mood States - Short Form
Time frame: Week 0 and Week 8
Exit Survey
Time frame: Week 8
Fear of Falling Questionnaire
Time frame: Week 0 and Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2014.
- Derived from this study: PubMed 26107256Jeter PE, Haaz Moonaz S, Bittner AK, Dagnelie G. Ashtanga-Based Yoga Therapy Increases the Sensory Contribution to Postural Stability in Visually-Impaired Persons at Risk for Falls as Measured by the Wii Balance Board: A Pilot Randomized Controlled Trial. PLoS One. 2015 Jun 24;10(6):e0129646. doi: 10.1371/journal.pone.0129646. eCollection 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ava Bittner, PhD, OD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga Intervention in people with Sleep Disturbance and Stress, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static Balance (time frame: Week 0 and Week 8.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01366677, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2014.