EFFECT OF TABLET MELATONIN FOR SLEEP PROBLEMS IN CHILDREN WITH CEREBRAL PALSY
Not Applicable
- Conditions
- Health Condition 1: G804- Ataxic cerebral palsyHealth Condition 2: G803- Athetoid cerebral palsyHealth Condition 3: G809- Cerebral palsy, unspecifiedHealth Condition 4: G808- Other cerebral palsyHealth Condition 5: G801- Spastic diplegic cerebral palsyHealth Condition 6: G802- Spastic hemiplegic cerebral palsyHealth Condition 7: G800- Spastic quadriplegic cerebral palsy
- Registration Number
- CTRI/2020/09/027813
- Lead Sponsor
- GIRE POOJA K
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
ALL THE CHILDREN DAIGNOSED WITH CEREBRAL PALSY AGE 3YRS TO 12 YRS WITH SLEEP PROBLEMS DEFINED BY PRESENCE OF ONE OR MORE OF THE FOLLOWING ;
1.WHO DID NOT FALL ASLEEP AFTER 1HR OF LIGHTS OFF.
2.WAKES UP ONCE OR MORE DURING NIGHT .
3.GETS LESS THAN 6HRS OF SLEEP
4.CHILDREN WHO FAIL BEHAVIORAL MANAGMENT STRATERGIES FOR SLEEP DISTURBANCES.
Exclusion Criteria
1.CHILDREN ALREADY TREATED WITH MELATONIN OR TAKING MELATONIN.
2.CHILDREN HAVING SYMPTOMS AND SIGNS OF OBSTRUCTIVE SLEEP APNEA.
3.KNOW ALLERGY TO MELATONIN.
4.CHILDREN WITH NOCTURNAL SEIZURES.
5.CHILDREN WHOSE PARENTS OR CARETAKERS ARE NOT WILLING TO PARICIPATE IN STUDY
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method TO IMPROVE TOTAL DURATION OF SLEEP BY 1 HOUR IN MELATONIN GROUP AS COMPARED TO PLACEBO GROUP.Timepoint: 3 MONTHS
- Secondary Outcome Measures
Name Time Method TO DECREASE SLEEP LATENCY IN MELATONIN GROUP AS COMPARED TO PLACEBO GROUPTimepoint: 3 MONTHS;TO STUDY SIDEEFFECTS OF MELATONIN IF ANYTimepoint: 3MONTHS